June 01, 2022 at 12:19AM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/8y5SIlD

Strawberries likely caused hepatitis A outbreak, FDA says - CBS News

1. Strawberries likely caused hepatitis A outbreak, FDA says  CBS News
2. Recall Alert: Hepatitis outbreak prompts strawberry recall | FOX 13 Seattle  FOX 13 Seattle
3. FDA investigating hepatitis A outbreak possibly linked to fresh strawberries  CNN
4. Organic strawberries linked to possible hepatitis A outbreak: FDA  13News Now
5. Strawberries sold at H-E-B are safe to consume  WOAI
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/iSLsjwG

Strawberries likely caused hepatitis A outbreak, FDA says - CBS News

1. Strawberries likely caused hepatitis A outbreak, FDA says  CBS News
2. FDA investigating hepatitis A outbreak possibly linked to fresh strawberries  CNN
3. Recall Alert: Hepatitis outbreak prompts strawberry recall | FOX 13 Seattle  FOX 13 Seattle
4. Virginia Beach farmer gives advice in wake of FDA report on organic strawberries  13newsnow.com WVEC
5. Strawberries linked to possible hepatitis A outbreak, FDA says  KSDK News

via Top stories - Google News https://ift.tt/AwYSj0s

Strawberries likely caused hepatitis A outbreak, FDA says - CBS News

1. Strawberries likely caused hepatitis A outbreak, FDA says  CBS News
2. FDA investigating hepatitis A outbreak possibly linked to fresh strawberries  CNN
3. Recall Alert: Hepatitis outbreak prompts strawberry recall | FOX 13 Seattle  FOX 13 Seattle
4. Virginia Beach farmer gives advice in wake of FDA report on organic strawberries  13newsnow.com WVEC
5. Strawberries linked to hepatitis outbreak  CBS Los Angeles
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/iSLsjwG

Strawberries likely caused hepatitis A outbreak, FDA says - CBS News

1. Strawberries likely caused hepatitis A outbreak, FDA says  CBS News
2. FDA investigating hepatitis A outbreak possibly linked to fresh strawberries  CNN
3. Strawberries linked to hepatitis outbreak  CBS Los Angeles
4. Virginia Beach farmer gives advice in wake of FDA report on organic strawberries  13newsnow.com WVEC
5. US, Canadian regulators tie hepatitis cases to some strawberry brands  KARE11.com

via Top stories - Google News https://ift.tt/AwYSj0s

Strawberries likely caused hepatitis A outbreak, FDA says - CBS News

1. Strawberries likely caused hepatitis A outbreak, FDA says  CBS News
2. FDA investigating hepatitis A outbreak possibly linked to fresh strawberries  CNN
3. Strawberries linked to hepatitis outbreak  CBS Los Angeles
4. US, Canadian regulators tie hepatitis cases to strawberries  The Washington Post
5. Fruit packer with Fresno office in hepatitis A recall  YourCentralValley.com
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/iSLsjwG

Strawberries likely caused hepatitis A outbreak, FDA says - CBS News

1. Strawberries likely caused hepatitis A outbreak, FDA says  CBS News
2. FDA investigating hepatitis A outbreak possibly linked to fresh strawberries  CNN
3. Strawberries linked to hepatitis outbreak  CBS Los Angeles
4. FDA investigating Hepatitis A outbreak linked to organic strawberries sold at major retailers  Fox Business
5. Strawberries linked to possible hepatitis A outbreak, FDA says  KSDK News

via Top stories - Google News https://ift.tt/AwYSj0s

Strawberry recall 2022: FDA investigating hepatitis A outbreak linked to fresh organic strawberries from Fresh Kampo and HEB - KABC-TV

1. Strawberry recall 2022: FDA investigating hepatitis A outbreak linked to fresh organic strawberries from Fresh Kampo and HEB  KABC-TV
2. FDA investigating Hepatitis A outbreak linked to organic strawberries  USA TODAY
3. FDA Recall: Strawberries sold nationwide linked to hepatitis A cases  WKBN.com
4. FDA: Strawberries sold nationwide linked to hepatitis A cases  Eyewitness News WEHT WTVW
5. Hepatitis A outbreak linked to strawberries sold at Kroger, Walmart, other grocery stores  WDIV ClickOnDetroit

via Top stories - Google News https://ift.tt/k5yYdEH

Hepatitis A outbreak linked to strawberries sold at Kroger, Walmart, other grocery stores - WDIV ClickOnDetroit

1. Hepatitis A outbreak linked to strawberries sold at Kroger, Walmart, other grocery stores  WDIV ClickOnDetroit
2. FDA Recall: Strawberries sold nationwide linked to hepatitis A cases  WKBN.com
3. FDA probing multi-state Hepatitis A outbreak linked to strawberries  Business Insider
4. FDA investigating hepatitis in strawberries at these grocers  KXAN.com
5. FDA investigating Hepatitis A outbreak linked to organic strawberries  USA TODAY
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/ljC53GL

Hepatitis A outbreak linked to strawberries sold at Kroger, Walmart, other grocery stores - WDIV ClickOnDetroit

1. Hepatitis A outbreak linked to strawberries sold at Kroger, Walmart, other grocery stores  WDIV ClickOnDetroit
2. FDA investigating hepatitis in strawberries at these grocers  KXAN.com
3. FDA probing multi-state Hepatitis A outbreak linked to strawberries  Business Insider
4. FDA: Strawberries sold nationwide linked to hepatitis A cases  KTVI Fox 2 St. Louis
5. FDA Investigating Hepatitis Outbreak in Strawberries  NBC 5 Dallas-Fort Worth

via Top stories - Google News https://ift.tt/UN29ZTj

Strawberries sold in grocery stores across the country recalled after Hepatitis A outbreak - FOX 13 Tampa

1. Strawberries sold in grocery stores across the country recalled after Hepatitis A outbreak  FOX 13 Tampa
2. The FDA is investigating a Hepatitis A outbreak linked to organic strawberries sold at Walmart, Trader Joe's and other retailers  Yahoo News
3. FDA investigating hepatitis in strawberries at these grocers  KXAN.com
4. FDA: Strawberries sold nationwide linked to hepatitis A cases  KTVI Fox 2 St. Louis
5. Strawberries sold at Walmart, Aldi, more, linked to hepatitis A outbreak, USDA says  AL.com
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/qHFyXNa

FDA investigating hepatitis in strawberries at these grocers - KXAN.com

1. FDA investigating hepatitis in strawberries at these grocers  KXAN.com
2. The FDA is investigating a Hepatitis A outbreak linked to organic strawberries sold at Walmart, Trader Joe's and other retailers  Yahoo News
3. FDA: Strawberries sold nationwide linked to hepatitis A cases  KTVI Fox 2 St. Louis
4. Strawberries sold at Walmart, Aldi, more, linked to hepatitis A outbreak, USDA says  AL.com
5. FDA: Strawberries sold nationwide potentially linked to hepatitis A cases  WKRC TV Cincinnati

via Top stories - Google News https://ift.tt/svDFYMI

FDA investigates HEB strawberries, another brand for hepatitis - KXAN.com

1. FDA investigates HEB strawberries, another brand for hepatitis  KXAN.com
2. The FDA is investigating a Hepatitis A outbreak linked to organic strawberries sold at Walmart, Trader Joe's and other retailers  Yahoo News
3. FDA Investigating Hepatitis Outbreak in Strawberries  NBC 5 Dallas-Fort Worth
4. FDA investigating hepatitis A outbreak possibly linked to strawberries  KARE11.com
5. FDA: Strawberries sold nationwide linked to hepatitis A cases  WeAreGreenBay.com
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/svDFYMI

May 26, 2022 at 09:12PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/UEiC458

May 26, 2022 at 09:08PM Carimune NF, Nanofiltered

Product approval is information indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), e.g., common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency.30,32-34 Carimune® NF is preferable to intramuscular Immune Globulin (Human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level28 , in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/lTsE6XA

May 26, 2022 at 09:06PM Flebogamma DIF 5% & 10%

Product approval information is indicated for:
•Flebogamma 5% DIF: Treatment of primary (inherited) immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.
•Flebogamma 10% DIF: Treatment of (1) primary (inherited) immunodeficiency; (2) chronic primary immune thrombocytopenia (ITP) in patients 2 years of age and older.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/WgmBMGZ

May 26, 2022 at 09:05PM Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates - 05/24/2022

New event page to promote CBER's annual patient engagement and regenerative medicine workshop. The webpage will include information about the event, including the agenda and event details. We would like the event to be featured here: https://ift.tt/ngmHSV0

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/SMZzLkK

May 26, 2022 at 09:04PM Vivaglobin

Product approval information is indicated for treatment of patients with primary immune deficiency (PID.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/cYtRHjI

May 26, 2022 at 09:00PM Anascorp

Anascorp is indicated for the treatment of clinical signs of scorpion envenomation.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/jiJBfmk

May 26, 2022 at 08:09PM Influenza Virus Vaccine, H5N1 (for National Stockpile)

For active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/hyuOSN2

May 26, 2022 at 07:16PM CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

CDER Scientific Reviews Supporting EUA for Therapeutic Products

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/9rwycDM

May 25, 2022 at 11:16PM Virus Entry and Its Inhibition by Antibodies: Studies to Aid the Development and Evaluation of Vaccines that Protect against Viral Infectious Diseases

A description of Carol Weiss's research program and related publications.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Cpvo5sr

May 25, 2022 at 05:29PM TachoSil

Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/SnqFDEH

May 24, 2022 at 10:29PM OTAT Learn

Welcome to OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn), the Center for Biologics, Evaluation and Research's (CBER) web page for industry education.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/z0ANkEe

May 24, 2022 at 12:44PM Licensed Biological Products with Supporting Documents

Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/treIUg5

May 24, 2022 at 10:12PM Importing CBER-Regulated Products into the United States

Importing CBER-Regulated Products into the United States

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/ocLJde1

May 24, 2022 at 03:31PM Roster of the Cellular, Tissue and Gene Therapies Advisory Committee

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/yftPaOr

May 24, 2022 at 03:16PM Roster of the Allergenic Products Advisory Committee

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/mWzNZql

May 24, 2022 at 01:37PM Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

In consultation with other federal partners, FDA has developed a list of drug and biological product essential medicines, drug, biological product, and device medical countermeasures, and critical inputs, as required by Executive Order 13944. FDA welcomes public comment on this list.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/CFwtOol

May 24, 2022 at 01:37PM Executive Order 14017 on America’s Supply Chains

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain, as directed by Executive Order 14017 on America’s Supply Chains

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/hr5XHWU

May 23, 2022 at 02:40PM Blood Guidances

This page contains a listing of Blood Guidances guidances.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/JIZn1oM

May 23, 2022 at 02:40PM Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

This Level 2 guidance updates the guidance of the same title dated April 2020.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/TMXFdJB

May 23, 2022 at 02:39PM Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements

This is the draft guidance Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirementso

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/LEIkXW2

May 23, 2022 at 02:23PM Animal Rule Information

Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/YtVRvBN

Jif peanut butter products recalled due to possible salmonella concerns - ABC News

1. Jif peanut butter products recalled due to possible salmonella concerns  ABC News
2. Voluntary recall for Jif peanut butter due to potential salmonella contamination  WFAA
3. Salmonella outbreak triggers recall of Jif peanut butter: What to know  WDIV ClickOnDetroit
4. Some Jif peanut butter products linked to salmonella cases, hospitalizations  NewsChannel 5
5. Peanut butter recall underway – Butler Eagle  Butler Eagle
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/vC8qeDn

Joe Biden on Monkeypox: 'Everybody Should Be Concerned' - Newsweek

1. Joe Biden on Monkeypox: 'Everybody Should Be Concerned'  Newsweek
2. President Biden Addresses Monkeypox Outbreak During Asia Visit  NBC News
3. Biden on Monkeypox: Outbreak should concern 'everybody,' as health experts are baffled  Fox News
4. Doctor says monkeypox epidemic should be contained soon  CBS News
5. Biden says monkeypox cases something to 'be concerned about'  KOMO News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/egJqSwB

Calls for caution as the number of monkeypox cases continues to rise globally - Sky News

1. Calls for caution as the number of monkeypox cases continues to rise globally  Sky News
2. ‘Urgency’: WHO expects more monkeypox cases globally  Al Jazeera English
3. Monkeypox Outbreak: Should We Be Alarmed?  On Demand News
4. Monkeypox Outbreak Prompts WHO to Explore Sexual Contact Theory: Adviser  Newsweek
5. WHO confirms 80 cases of monkeypox, but how it's spreading remains a m  CityNews

via Top stories - Google News https://ift.tt/usXO91J

Biden on monkeypox: 'Everybody' should be concerned about spread - The Washington Post

1. Biden on monkeypox: 'Everybody' should be concerned about spread  The Washington Post
2. Biden on Monkeypox: Outbreak should concern 'everybody,' as health experts are baffled  Fox News
3. Biden on monkeypox: 'Everybody' should be concerned, spread would be 'consequential'  Yahoo News
4. Biden says monkeypox cases something to 'be concerned about'  WIBW
5. Biden says ‘everybody’ should be concerned about spread of monkeypox  The Guardian US
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/BecDCfi

Monkeypox virus spreading worldwide: 80 cases in 11 countries - KTVU FOX 2 San Francisco

1. Monkeypox virus spreading worldwide: 80 cases in 11 countries  KTVU FOX 2 San Francisco
2. Monkeypox outbreak: WHO working on sexual contact theory, top adviser says  The Guardian US
3. WHO calls emergency meeting as monkeypox cases rise  Reuters
4. Imran Khan News Updates: Imran Khan again praises India for reducing fuel prices  Economic Times
5. WHO confirms 80 cases of monkeypox, but how it's spreading remains a m  CityNews
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/ydXV8U2

North Korea claims 'positive trend' in Covid outbreak, but no reply to Biden's offer of help - CNN

North Korea claims 'positive trend' in Covid outbreak, but no reply to Biden's offer of help  CNNView Full Coverage on Google News

via Top stories - Google News https://ift.tt/AmeKM2T

J.M. Smucker is recalling some Jif peanut butter products due to salmonella - CNN

1. J.M. Smucker is recalling some Jif peanut butter products due to salmonella  CNN
2. Recall alert: Some Jif peanut butter products recalled by J. M. Smucker  KIRO Seattle
3. Jif peanut butter recall announced over salmonella concerns  USA TODAY
4. Jif peanut butter recalled amid multistate salmonella outbreak  FOX 6 Milwaukee
5. RECALL: Some Jif peanut butter products could be contaminated with salmonella  KSAT San Antonio
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/EwPxar6

May 20, 2022 at 11:06PM COBAS AmpliScreen HBV Test

Product approval information is indicated for:
• Qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma from donations of Whole Blood and blood components for transfusion, and Source Plasma
• Testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/jK63ZyT

May 20, 2022 at 10:33PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Zk7BIlE

May 20, 2022 at 10:24PM HIBERIX

HIBERIX is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/0oY2Ntb

May 20, 2022 at 08:31PM Jobs at the Center for Biologics Evaluation and Research (CBER)

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/8AUjQF2

May 20, 2022 at 07:54PM Profilnine SD - Factor IX Complex

Product approval information is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/kiTaSBq

May 20, 2022 at 07:34PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/K9JrDyU

May 20, 2022 at 07:33PM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/oCv35T9

May 19, 2022 at 04:14PM Administrative Guidances

This page lists Administrative Guidance documents.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/JsmQwkc

May 19, 2022 at 02:49PM FDA's “All-in” Approach to Enterprise Transformation

The Enterprise Modernization Action Plan is the next phase of FDA’s data and technology transformation and describes our plans to shape the agency’s future by delivering successful cross-agency efforts that optimize common and essential business processes.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/F298lIJ

May 19, 2022 at 02:31PM Know Your Treatment Options for COVID-19

Patients today have more treatment options in the battle against coronavirus disease. FDA has approved two drug treatments for COVID-19 and authorized others for emergency use during this public health emergency.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Y043hyr

Here's what we know about North Korea's COVID outbreak — and its ability to handle it - NPR

1. Here's what we know about North Korea's COVID outbreak — and its ability to handle it  NPR
2. Covid is 'explosively' spreading through North Korea. What does this mean for Kim Jong Un?  NBC News
3. The world's hidden pandemic  CNN
4. Editorial: North Korea looks dangerously vulnerable in the face of omicron  Chicago Tribune
5. Tea and infomercials: N. Korea fights COVID with few tools  The Associated Press

via Top stories - Google News https://ift.tt/1FVj3J2

May 19, 2022 at 11:45AM Blood Grouping Reagent, Anti-Fya ALBAsera

Product approval information is indicated for the detection and identification of the Fya positive red blood cells by indirect agglutination.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/rliPKED

May 19, 2022 at 11:41AM Erytype S

Product approval information is indicated for use on the Erytype® S Rh + K Type plate for Rh and Kell typing on the TANGO® optimo automated blood grouping and antibody test system. Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype® S Rh+K Type plate for Rh typing on the TANGO® optimo automated blood grouping and antibody test system. Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO® optimo system.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/icspOhe

May 18, 2022 at 06:17PM Cellular, Tissue, and Gene Therapies Advisory Committee June 9-10, 2022 Meeting Announcement - 06/09/2022

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee June 9-10, 2022 Meeting Announcement.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/azJrQyv

May 18, 2022 at 04:08PM Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement - 03/10/2022

This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting Announcement.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/jDUZlNe

May 18, 2022 at 03:32PM Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use)

Blood Grouping Reagent, Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use)

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/G0jBtNF

May 18, 2022 at 01:27PM LAVIV

LAVIV is indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/usGH5xK

May 18, 2022 at 01:12PM Alinity s HBsAg and Alinity s HBsAg Confirmatory

The Alinity s HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. The Alinity s HBsAg assay is intended to screen individual human donors, including

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/dMQHBVZ

May 18, 2022 at 01:03PM ReFacto

Product approval information for Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/yHZzC5m

North Korea hails recovery as WHO worries over missing data - The Associated Press

1. North Korea hails recovery as WHO worries over missing data  The Associated Press
2. North Korean leader Kim slams officials' 'immaturity' in response to COVID outbreak  Reuters
3. N. Korea reports another jump in suspected COVID-19 cases  Idaho Press
4. Kim rounds on ‘slack’ officials as COVID outbreak rages  Al Jazeera English
5. From storage to transport, hurdles to getting COVID vaccine to North Koreans  Reuters
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/35CQkbG

North Korea's Kim Jong Un blames "irresponsible" workers for apparent explosion in COVID-19 cases - CBS News

1. North Korea's Kim Jong Un blames "irresponsible" workers for apparent explosion in COVID-19 cases  CBS News
2. There's One Reason Kim Jong Un Is Loving NK's COVID Outbreak  The Daily Beast
3. North Korea's COVID-19 crisis is quickly spiraling out of control — officials say more than 1.4 million people are now suffering from 'fever'  Yahoo News
4. N. Korea reports another jump in suspected COVID-19 cases – KION546  KION
5. N. Korea reports another jump in suspected COVID-19 cases  ABC News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/MkszDj2

North Korea reports surge in COVID deaths, Kim Jong Un slams slow response - New York Post

1. North Korea reports surge in COVID deaths, Kim Jong Un slams slow response  New York Post
2. Kim Jong Un slams North Korean officials over COVID-19 response  Fox News
3. North Korea reports more deaths amid COVID lockdown  Reuters
4. Kim Jong Un mobilizes North Korea's military in response to Covid-19 outbreak  CNN
5. North Korea Reports 15 More COVID Deaths in its First Wave of Pandemic  The Daily Beast

via Top stories - Google News https://ift.tt/xEUWI9g

North Korea reports surge in COVID deaths, Kim Jong Un slams slow response - New York Post

1. North Korea reports surge in COVID deaths, Kim Jong Un slams slow response  New York Post
2. Kim Jong Un slams North Korean officials over COVID-19 response  Fox News
3. North Korea reports more deaths amid COVID lockdown  Reuters
4. Kim Jong Un mobilizes North Korea's military in response to Covid-19 outbreak  CNN
5. North Korea Reports 15 More COVID Deaths in its First Wave of Pandemic  The Daily Beast
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/7GC4MRY

May 16, 2022 at 07:48PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/AiXxO5o

May 16, 2022 at 06:20PM Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/ZudQOaF

Kim blasts pandemic response as North Korean outbreak surges - ABC News

1. Kim blasts pandemic response as North Korean outbreak surges  ABC News
2. North Korea reports more deaths amid COVID lockdown  Reuters
3. Kim Jong Un slams North Korean officials over COVID-19 response  Fox News
4. Kim Jong Un mobilizes North Korea's military in response to Covid-19 outbreak  CNN
5. Lacking vaccines, North Korea battles COVID with antibiotics, home remedies  Reuters

via Top stories - Google News https://ift.tt/yzcWFGe

May 16, 2022 at 02:06PM FDA Patient Engagement Partnerships

FDA Patient Engagement Partnerships

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/1BPObWF

Kim Jong Un orders North Korea military to 'stabilize' drug supply amid COVID outbreak - Reuters

1. Kim Jong Un orders North Korea military to 'stabilize' drug supply amid COVID outbreak  Reuters
2. N Korean leader sends in military to help tackle COVID outbreak  Al Jazeera English
3. North Korea Reports 8 Deaths as Kim Laments Virus Response  U.S. News & World Report
4. North Korea reports more deaths amid COVID lockdown  Reuters
5. Kim blasts pandemic response as North Korean outbreak surges  ABC News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/vmD65f3

What we know (and don't know) about North Korea's Covid outbreak - CNN

1. What we know (and don't know) about North Korea's Covid outbreak  CNN
2. North Korea reports 15 more suspected COVID-19 deaths  NPR
3. North Korea reports 15 deaths and nearly 300,000 new ‘fever’ cases as Covid outbreak spreads  The Guardian
4. Opinion | North Korea sees a virus explosion. Its missiles won't help.  The Washington Post
5. North Korea's Kim Jong Un calls for unity as COVID-19 cases rise  New York Post
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3pWQezS

North Korea reports more deaths, says taking 'swift measures' against COVID outbreak - Reuters

North Korea reports more deaths, says taking 'swift measures' against COVID outbreak  ReutersView Full Coverage on Google News

via Top stories - Google News https://ift.tt/HNmTuZ3

North Korea reports 15 deaths and nearly 300,000 new ‘fever’ cases as Covid outbreak spreads - The Guardian

1. North Korea reports 15 deaths and nearly 300,000 new ‘fever’ cases as Covid outbreak spreads  The Guardian
2. What we know (and don't know) about North Korea's Covid outbreak  CNN
3. North Korea reports 15 more COVID-19 suspected deaths  ABC News
4. Opinion | North Korea sees a virus explosion. Its missiles won't help.  The Washington Post
5. North Korea Reports 15 More Suspected COVID-19 Deaths  U.S. News & World Report

via Top stories - Google News https://ift.tt/eF2Vh7f

North Korea confirms 21 new deaths as it battles COVID-19 - The Associated Press

1. North Korea confirms 21 new deaths as it battles COVID-19  The Associated Press
2. North Korea said it is suffering an explosive outbreak of 'fever' with 350,000 cases — just one day after announcing its first ever COVID case  Yahoo News
3. N. Korea reports 6 deaths after admitting COVID-19 outbreak  The Associated Press
4. Opinion | North Korea sees a virus explosion. Its missiles won't help.  The Washington Post
5. What we know (and don't know) about North Korea's Covid outbreak  CNN

via Top stories - Google News https://ift.tt/cam1d3J

North Korea confirms 21 new deaths as it battles COVID-19 - The Associated Press

1. North Korea confirms 21 new deaths as it battles COVID-19  The Associated Press
2. North Korea has 'explosive' outbreak of fever after 1st COVID case  Business Insider
3. North Korea announces first Covid deaths amid 'explosive' outbreak  CNN
4. Opinion | North Korea sees a virus explosion. Its missiles won't help.  The Washington Post
5. North Korea reports 21 new deaths amid efforts to mitigate COVID-19  Fox News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/cam1d3J

North Korea confirms 21 new deaths as it battles COVID-19 - The Associated Press

1. North Korea confirms 21 new deaths as it battles COVID-19  The Associated Press
2. North Korea has 'explosive' outbreak of fever after 1st COVID case  Business Insider
3. North Korea announces first Covid deaths amid 'explosive' outbreak  CNN
4. Opinion | North Korea sees a virus explosion. Its missiles won't help.  The Washington Post
5. North Korea reports 21 new deaths amid efforts to mitigate COVID-19  Fox News

via Top stories - Google News https://ift.tt/cam1d3J

North Korea confirms 21 new deaths as it battles COVID-19 - The Associated Press

1. North Korea confirms 21 new deaths as it battles COVID-19  The Associated Press
2. North Korea announces first Covid deaths amid 'explosive' outbreak  CNN
3. North Korea has 'explosive' outbreak of fever after 1st COVID case  Business Insider
4. Opinion | North Korea sees a virus explosion. Its missiles won't help.  The Washington Post
5. North Korea Cops to 'First' COVID-19 Deaths After Outbreak Prompts Lockdown  The Daily Beast
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/cam1d3J

North Korea: Kim Jong-un declares Covid outbreak a ‘great disaster’ - The Guardian

North Korea: Kim Jong-un declares Covid outbreak a ‘great disaster’  The GuardianView Full Coverage on Google News

via Top stories - Google News https://ift.tt/slVuzBL

May 13, 2022 at 09:50PM Section 8100: Communication

This is the CBER SOPP Section 8100: Communication main page.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/XwHylL3

May 13, 2022 at 08:21PM HCT/P Inspection Information

This is the main page for the CBER HCT/P Inspection Information.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/JtW2Hvq

May 13, 2022 at 03:26PM GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)

GINTUIT is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/sgriMyX

N. Korea reports 6 deaths after admitting COVID-19 outbreak - The Associated Press

1. N. Korea reports 6 deaths after admitting COVID-19 outbreak  The Associated Press
2. North Korea announces first Covid deaths amid 'explosive' outbreak  CNN
3. North Korea and Eritrea are the only two countries without vaccines  The Washington Post
4. North Korea confirms 1st COVID outbreak, Kim orders lockdown  The Associated Press
5. North Korea admitting to its first COVID 19 case: CBS News Flash May 12, 2022  CBS News

via Top stories - Google News https://ift.tt/jx2SYEN

North Korea and Eritrea are the only two countries without vaccines - The Washington Post

1. North Korea and Eritrea are the only two countries without vaccines  The Washington Post
2. North Korea's Kim Wears Face Mask As First Covid Cases Acknowledged  NBC News
3. No plans now to share COVID vaccines with North Korea, White House says  Reuters.com
4. North Korea confirms 1st COVID outbreak, Kim orders lockdown  The Associated Press
5. North Korea admitting to its first COVID 19 case: CBS News Flash May 12, 2022  CBS News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/6yL1TYK

North Korea and Eritrea are the only two countries without vaccines - The Washington Post

1. North Korea and Eritrea are the only two countries without vaccines  The Washington Post
2. North Korea reports first COVID-19 outbreak, orders lockdown  Reuters
3. North Korea confirms 1st COVID outbreak, Kim orders lockdown  Yahoo News
4. North Korea admitting to its first COVID 19 case: CBS News Flash May 12, 2022  CBS News
5. North Korea reports 6 deaths after admitting COVID-19 outbreak  Honolulu Star-Advertiser

via Top stories - Google News https://ift.tt/6yL1TYK

May 12, 2022 at 04:08PM Aptima HIV-1 Quant Dx Assay

Aptima HIV-1 Quant Dx Assay is an in vitro nucleic acid amplification test (NAAT) for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals on the fully automated Panther system.

via Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/aptima-hiv-1-quant-dx-assay

May 11, 2022 at 09:59PM Janssen COVID-19 Vaccine Frequently Asked Questions

Answers to frequently asked questions about FDA's Emergency Use Authorization of the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/IurEGK2

May 11, 2022 at 07:47PM Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic

COVID-19

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/0NUnhew

May 11, 2022 at 06:28PM How do I request a Patient Listening Session?

Learn about how to request a Patient Listening Session with the FDA to share your experiences and perspectives.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/FJwNg2X

May 11, 2022 at 06:28PM Application Submissions Guidances

This page lists Application Submissions Guidance documents.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2ouxekn

May 11, 2022 at 06:26PM How do I prepare for a Patient Listening Session?

Learn about how you can prepare to participate in a Patient Listening Session. Patient Listening Sessions can be FDA-requested or patient-led.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/IZvhWMR

May 11, 2022 at 05:25PM Bivigam

Product approval information is indicated for the treatment of primary humoral immunodeficiency (PI).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/kMHJeOt

May 10, 2022 at 12:54PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/7Fn6Rlx

May 09, 2022 at 10:20PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022

This is the list of guidance topics CBER is considering for development during Calendar Year 2022

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/PEcKDy6

May 09, 2022 at 10:07PM Exporting CBER-Regulated Products

The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved CBER-regulated products.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Apx3gLv

May 09, 2022 at 10:02PM Clinical Investigator Status (Biologics)

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/uZFrMVf

May 09, 2022 at 09:31PM Clinical Investigator Inspection List T-Z

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Hqm7WP

May 09, 2022 at 09:06PM Clinical Investigator Inspection List L-P

Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/J4TA73F

May 09, 2022 at 09:01PM Clinical Investigator Inspection List Q-S

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/rLq1gip

May 09, 2022 at 08:19PM cobas TaqScreen MPX Test, version 2.0

Product approval information for
•Direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in human plasma.
•Simultaneous detection and discrimination of HIV RNA, HCV RNA, and HBV DNA.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/NadguVL

May 09, 2022 at 03:58PM cobas MPX

cobas MPX Test, for use on the cobas 6800/8800 Systems
Direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in human plasma
Simultaneous detection and discrimination of HIV RNA, HCV RNA, and HBV DNA in human donor plasma or serum specimens

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/8ofqH4L

May 09, 2022 at 02:50PM YESCARTA (axicabtagene ciloleucel)

YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/nHLb1GD

May 06, 2022 at 09:29PM KYMRIAH (tisagenlecleucel)

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/HIgxOVk

May 06, 2022 at 08:14PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/CXbNwIK

May 06, 2022 at 07:41PM Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates - 05/24/2022

New event page to promote CBER's annual patient engagement and regenerative medicine workshop. The webpage will include information about the event, including the agenda and event details. We would like the event to be featured here: https://ift.tt/wd5y9h0

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/oFgKL0q

May 06, 2022 at 05:06PM Janssen COVID-19 Vaccine

Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/l7TSCMa

May 06, 2022 at 05:00PM Recalls (Biologics)

Biologic recalls are listed by year. Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/aSwMOCp

May 06, 2022 at 04:17PM Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Z5lpXQI

May 06, 2022 at 02:39PM BIMO/Team Biologics/Internet Surveillance/Other

This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/YoBPZXH

Xi Jinping sends warning to anyone who questions China's zero-Covid policy - CNN

1. Xi Jinping sends warning to anyone who questions China's zero-Covid policy  CNN
2. China’s Covid Lockdowns Leave Millions Out of Work  The New York Times
3. Xi Gets Tough to Stem Growing Dissent on Covid  Bloomberg
4. Xi Jinping attacks ‘doubters’ as he doubles down on China’s zero-Covid policy  The Guardian
5. As Beijing outbreak persists, China hits back at 'zero COVID' doubters  Reuters
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/EGbDM8v

May 05, 2022 at 09:03PM Spikevax and Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine and Spikevax

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/lvebJMC

May 05, 2022 at 05:38PM Safety & Availability (Biologics)

Important information about the safety and availability of biological products.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/8uCUf9Q

iPhone City goes into immediate lockdown after COVID-19 outbreak; recruitment suspended - 9to5Mac

1. iPhone City goes into immediate lockdown after COVID-19 outbreak; recruitment suspended  9to5Mac
2. iPhone 14 delay fears have Apple pulling out all the stops  TechRadar
3. Foxconn Abruptly Halts Hiring at iPhone Factory Amid New Lockdown and iPhone 14 Delay Concerns  MacRumors
4. iPhone 14 delay fears beginning to materialize as largest assembler freezes hiring  PhoneArena
5. iPhone 14 delays could be on the horizon — here's why  Tom's Guide
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/eO8EK2u

May 04, 2022 at 09:53PM IMLYGIC

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/v91qz0h

May 04, 2022 at 04:58PM HPC, Cord Blood - LifeSouth

For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myelo

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/uHv2Kpr

May 04, 2022 at 04:51PM HPC, Cord Blood - Bloodworks

The approval letter for Bloodworks Biologics License Application for HPC, Cord Blood - BLA 125585 is indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/gEabMhz