U.S. restricting travel from India amid raging COVID outbreak - CBS News

U.S. restricting travel from India amid raging COVID outbreak  CBS NewsView Full Coverage on Google News

via Top stories - Google News https://ift.tt/3u9XcTN

April 30, 2021 at 01:34PM FDA Informs Collection Establishments of CDC-Identified Potential Increased Zika Virus Risk to Blood and Tissue Safety in Florida’s Miami-Dade, Palm Beach, and Broward Counties

March 13, 2017: FDA is informing establishments that collect tissues (HCT/Ps) and blood components of potential increased risk due to Zika virus, so they may consider whether and how this new information impacts their practices

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

April 29, 2021 at 04:03AM MCM-Related Guidance by Date

Guidances and other information of special interest to MCM stakeholders, sponsors and applicants, listed by date

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

India's ruling party leader says 'responsibility is ours' for Covid-19 outbreak - CNN

1. India's ruling party leader says 'responsibility is ours' for Covid-19 outbreak  CNN
2. The Indian Government Is Silencing Critics Even As Its COVID-19 Crisis Surges  TIME
3. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3gMMC19

April 29, 2021 at 02:46PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/30kpooc

April 29, 2021 at 02:26AM 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/2Law18L

April 27, 2021 at 11:55PM A Method for Detection of SARS-CoV-2 RNA in Healthy Human Stool: A Validation Study

Scientists have published the results of a study that evaluated the method for the detection of SARS-CoV-2 RNA in fecal samples. This method has potential uses in stool donor screening, sewage monitoring, and further research into the impact of fecal shedding on the epidemiology of this pandemic.

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

April 27, 2021 at 10:04PM Innovation and Regulatory Science

Innovation and Regulatory Science

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2XI4jqs

April 27, 2021 at 09:03PM Coronavirus (COVID-19) Update: April 27, 2021

Coronavirus (COVID-19) Update: April 27, 2021

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/32SNLMB

India “running out of vaccines” as Covid crisis deepens - BBC News - BBC News

1. India “running out of vaccines” as Covid crisis deepens - BBC News  BBC News
2. Photos show the deadly toll of Covid in India as coronavirus cases top 17 million  CNBC
3. SOS messages, panic as virus breaks India's health system  Yahoo News
4. U.S. to Send Virus-Ravaged India Materials for Vaccines  The New York Times
5. Two die and more than 100 test positive in coronavirus outbreak among US diplomatic staff in India  CNN
6. View Full Coverage on Google News

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

April 26, 2021 at 09:08PM Class II Special Controls Documents

This page lists special controls guidance and guideline documents developed by CDRH and other FDA Centers.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2T3HjOA

April 26, 2021 at 07:39PM Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria

Addresses section 704(g) of the FDCA which concerns the accreditation of third parties to conduct inspections of manufacturers of class II/III devices.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3xpDfu9

April 26, 2021 at 07:33PM References for the Regulatory Process for the Office of Tissues and Advanced Therapies

Thank you for inquiring with the Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) regarding your proposed product.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2R0qANw

April 26, 2021 at 07:30PM Industry (Biologics)

CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

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

April 26, 2021 at 07:25PM Development & Approval Process (CBER)

Key resources and information related to CBER development & approval process.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Z9cLwL

April 26, 2021 at 07:13PM Approved Blood Products

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3oCV0RY

April 26, 2021 at 07:09PM Quick Guide to Web Resources

Quick Guide to Web Resources

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/32NnAWQ

April 26, 2021 at 05:49PM Hizentra

Product approval information is indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

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

April 26, 2021 at 04:39PM Resources for You (Biologics)

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2B32Ltn

U.S. Pledges Medical Aid To India, Where COVID-19 Is Overwhelming Hospitals - NPR

1. U.S. Pledges Medical Aid To India, Where COVID-19 Is Overwhelming Hospitals  NPR
2. Fauci Says US May Send AstraZeneca Vaccine to India to Combat Covid Surge  Bloomberg
3. Biden administration will deploy additional supplies and support to India as country faces Covid-19 outbreak  CNN
4. Biden’s ‘America First Lite’ policies on vaccine sharing, refugees are awful look for U.S. | Will Bunch  The Philadelphia Inquirer
5. U.S. Pledges Medical Aid as Coronavirus Surge Devastates India  Slate
6. View Full Coverage on Google News

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

April 24, 2021 at 12:56AM FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3sMcwof

April 23, 2021 at 10:17PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Yc9luW

April 23, 2021 at 06:58PM Section 9150: Office of Tissues and Advanced Therapies

This is the SOPP Section 9150: Office of Tissues and Advanced Therapies.

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

April 23, 2021 at 06:54PM Section 8500: Compliance

This is the SOPP Section 8500: Compliance main page.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2oG9Rl9

April 23, 2021 at 06:51PM Section 8400: Marketing Applications

This is the SOPP Section 8400: Marketing Applications main page.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2U9zYMz

April 23, 2021 at 06:45PM Section 8200: Investigational New Drugs (INDs)

This is the SOPP Section 8200: Investigational New Drugs (INDs) main page.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2II4N6y

April 23, 2021 at 06:23PM Section 8100: Communication

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/32clCxw

April 23, 2021 at 06:20PM Section 8000: General Information

This is the main page for CBER's SOPP Section 8000: General Information.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/322hgJI

How long does protection from COVID-19 vaccines last? - WOODTV.com

1. How long does protection from COVID-19 vaccines last?  WOODTV.com
2. An unvaccinated worker set off an outbreak at a U.S. nursing home where most residents were immunized.  The New York Times
3. US has the opportunity to overcome the Covid-19 pandemic but a major challenge lies ahead, expert says  CNN
4. The Really Surprising Thing About Fully Vaccinated People Who Get COVID-19  Slate
5. CDC is considering revising its outdoor mask guidance. Here's what health experts say.  Yahoo News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3tJTj7T

April 22, 2021 at 07:53PM Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1

Products approval information are designated as Rare Antisera for Column Agglutination Technology (RASCAT) Monoclonal Blood Grouping Reagents (BGRs) and are manufactured for use with the Ortho ID-Micro Typing System™.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3emWQmi

The latest on the coronavirus pandemic and vaccines: Live updates - CNN

1. The latest on the coronavirus pandemic and vaccines: Live updates  CNN
2. Coronavirus transmissibility adapting through different variants: Infectious diseases specialist  CNA
3. An unvaccinated worker set off an outbreak at a U.S. nursing home where most residents were immunized.  The New York Times
4. Only 2 'breakthrough' infections among hundreds of fully vaccinated people, new study finds  CNN
5. Push to create vaccine health pass  ABC 10 News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/2Qi9I5c

Coronavirus outbreak in Kentucky nursing home linked to R.1 variant, prompts concern over vaccine impact - Fox News

1. Coronavirus outbreak in Kentucky nursing home linked to R.1 variant, prompts concern over vaccine impact  Fox News
2. US may soon reach a tipping point on Covid-19 vaccine demand. Here's why that's concerning  CNN
3. Dr. Vanderhoff answers the question: Can I still contract the coronavirus after being vaccinated?  NBC4 Columbus
4. An unvaccinated worker set off an outbreak at a U.S. nursing home where most residents were immunized.  The New York Times
5. Your Story: US yet to respond on ban on export of COVID-19 vaccine raw material |Latest English News  WION
6. View Full Coverage on Google News

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

April 21, 2021 at 04:56PM FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability

This is the FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2ANyjH9

April 21, 2021 at 04:44PM Guidance for Human Somatic Cell Therapy and Gene Therapy

Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy, CBER, Biologics

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

April 21, 2021 at 03:57PM Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications

This is the Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3apjFV6

April 21, 2021 at 03:51PM Advancing the Development of Safe and Effective Regenerative Medicine Products

Innovative medical products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3niSukh

April 21, 2021 at 03:22PM Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation

Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2P9kIBf

April 21, 2021 at 03:15PM FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3xeTPwH

April 21, 2021 at 02:02PM Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

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

Asian markets slump on worsening coronavirus outbreaks - MarketWatch

Asian markets slump on worsening coronavirus outbreaks  MarketWatch

via Top stories - Google News https://ift.tt/3n4zmX3

Asian markets slump on worsening coronavirus outbreaks - MarketWatch

Asian markets slump on worsening coronavirus outbreaks  MarketWatchView Full Coverage on Google News

via Top stories - Google News https://ift.tt/3n4zmX3

April 19, 2021 at 09:04PM CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action

Health Fraud products are articles of unproven effectiveness that are promoted to improve health, well being, or appearance. They can be drugs, devices, foods or cosmetics for human or animal use.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3bNjDp0

April 19, 2021 at 02:28PM RAGWITEK

Product approval information for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen approved for use in adults 18 through 65 years of age.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2RC2ysz

Authorities investigate after blood clot death likely linked to AstraZeneca vaccine | ABC News - ABC News (Australia)

1. Authorities investigate after blood clot death likely linked to AstraZeneca vaccine | ABC News  ABC News (Australia)
2. Covid-19: World’s Virus Death Toll Nears 3 Million  The New York Times
3. Virus Outbreak: News and Analysis From April 17  Bloomberg
4. Understanding the blood clot issue behind the AstraZeneca vaccine and its safety  Toronto Star
5. Breda O’Brien: Healthcare students bullied into taking AstraZeneca vaccine  The Irish Times
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3mUL2vi

Virus Outbreak: News and Analysis From April 17 - Bloomberg

Virus Outbreak: News and Analysis From April 17  Bloomberg

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

West Virginia Has A Massive HIV Outbreak And It Just Restricted Something That Could End It - BuzzFeed News

1. West Virginia Has A Massive HIV Outbreak And It Just Restricted Something That Could End It  BuzzFeed News
2. Brazilian variant of COVID-19 detected in W.Va. according to Governor  WSAZ-TV
3. First two cases of more contagious Brazilian COVID variant identified in Virginia  8News
4. 475 more COVID-19 patients discharged in Virginia, hospitalizations tick down  wtvr.com
5. Video, updates: Governor's briefing on covid response at 10:30  West Virginia MetroNews
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3sr8qS8

April 16, 2021 at 11:18PM ANAVIP

Product approval information is indicated for the management of adult and pediatric patients with North American rattlesnake envenomation.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2n0yo3t

April 16, 2021 at 09:31PM Coronavirus (COVID-19) Update: April 16, 2021

Coronavirus (COVID-19) Update: April 16, 2021

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

April 16, 2021 at 07:35PM What happens after a Patient Listening Session?

Learn about what happens after a Patient Listening Session occurs and check out summaries from previous sessions on our website.

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

April 16, 2021 at 06:04PM How does FDA benefit from Patient Listening Sessions?

Learn how FDA benefits from Patient Listening Sessions, such as understanding what is important to patients, caregivers, and patient advocates when medical products are being developed.

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

La Soufrière Volcano: A Growing Humanitarian Crisis - NPR

1. La Soufrière Volcano: A Growing Humanitarian Crisis  NPR
2. St. Vincent fears COVID-19 outbreak as positive cases climb after volcano eruption  Fox News
3. Roughly 20,000 people displaced by ongoing volcanic eruptions in St. Vincent  NBC News
4. Humanitarian crisis feared in St. Vincent amid eruptions  New York Post
5. Volcano continues rocking Caribbean island of St. Vincent. UN appeals for international help  Miami Herald
6. View Full Coverage on Google News

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

April 15, 2021 at 04:35PM Bacterial Vaccine Safety: Biomarkers of Virulence and Attenuation in Bordetella Pertussis (Whooping Cough) and Anthrax Bacteria

A description of E. Scott Stibitz's research program and related publications.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3wYlsu8

April 15, 2021 at 04:22PM Evaluating Viral Antigens and Antibody Neutralization for HIV/AIDS, Smallpox, and Influenza

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3mQvZmb

April 14, 2021 at 11:47PM Vaccines Research

List of Vaccines Research.

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

April 14, 2021 at 11:22PM Tissue & Advanced Therapies Research

This page is about Tissue & Advanced Therapies Research

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2B4RpYX

April 14, 2021 at 07:36PM Model Informed Drug Development Approaches for Immunogenicity Assessments - 06/09/2021 - 06/09/2021

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), in collaboration with the Center for Drug Evaluation and Research (CDER), are announcing the following public workshop entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments.”

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3dZmJbG

April 14, 2021 at 06:55PM 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/3uz7cH3

April 14, 2021 at 06:48PM FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

FDA releases guidance on how remote interactive evaluations will be requested by FDA and conducted for the duration of COVID-19 at drug facilities.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3dh98NC

April 14, 2021 at 06:20PM Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency

Guidance for Industry


via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3aaYR3C

April 13, 2021 at 07:31PM Coronavirus (COVID-19) Update: April 13, 2021

Coronavirus (COVID-19) Update: April 13, 2021

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3thBpJp

April 13, 2021 at 01:52PM Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3a5kjqC

April 13, 2021 at 01:14AM 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

This is the main page for the CBER 2021 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee.

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

The C.D.C. director says Michigan needs to shut down, not get extra vaccine, to slow its virus outbreak. - The New York Times

The C.D.C. director says Michigan needs to shut down, not get extra vaccine, to slow its virus outbreak.  The New York TimesView Full Coverage on Google News

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

April 13, 2021 at 12:10AM Devices Guidances

This page lists Medical Device Guidance documents.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2SaRU8A

April 12, 2021 at 08:16PM Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities

As FDA celebrates National Minority Health Month we’re working to address concerns about vaccines among diverse communities.

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

April 12, 2021 at 04:02PM Premarket Approval (PMA) Process (CBER)

Premarket Approval (PMA) Process (CBER)

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2Nz8fpa

April 12, 2021 at 04:01PM New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products

Historically, CBER has regulatory jurisdiction over some NDA products. Most NDAs are reviewed by the Center for Drug Evaluation and Research (CDER). There are only a few ANDAs currently regulated at CBER, e.g., ANDAs related to blood transfusion products. Most ANDAs are reviewed by CDER.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2YsbHE1

April 12, 2021 at 03:55PM Labeling for CBER-Regulated Products

Labeling for CBER-Regulated Products

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3uJ5xOm

April 12, 2021 at 03:52PM Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER)

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

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

April 12, 2021 at 03:50PM Biologics License Applications (BLA) Process (CBER)

The Biologics License Application is used to request permission to introduce, or deliver a biologic product into interstate commerce.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3nUV1QL

April 12, 2021 at 03:47PM 510(k) Process (CBER)

510(k) Process (CBER)

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

April 12, 2021 at 03:45PM Vaccine Development – 101

FDA’s Center for Biologics Evaluation and Research (CBER) ensures that FDA’s rigorous scientific and regulatory processes are followed by those who pursue the development of vaccines.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3kOQoWj

April 12, 2021 at 03:42PM Biological Approvals by Year

A collection of biological approval information organized by year and regulatory authorities.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/391klO2

April 12, 2021 at 02:32PM Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2021

This is the list of guidance topics CBER is considering for development during Calendar Year 2021.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2YE2vwQ

Virus Outbreak: News and Analysis From April 11 - Bloomberg

1. Virus Outbreak: News and Analysis From April 11  Bloomberg
2. Covid-19: Case Rates for U.S. Prisoners Have Been Triple Those of Other Americans  The New York Times
3. Covid-19 Pandemic: Live Updates and News for Apr. 10, 2021  Bloomberg
4. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3g04fKB

At least two killed as severe weather sweeps through Gulf Coast - CBS News

1. At least two killed as severe weather sweeps through Gulf Coast  CBS News
2. Severe weather forecast for parts of Gulf Coast; at least 2 dead in Louisiana  CNN
3. Severe storms barrel toward Charlotte with ‘damaging’ winds. Here’s the latest.  Charlotte Observer
4. Severe Outbreak With Widespread Damaging Thunderstorm Winds and Hail Wrapping Up Near the Gulf Coast  Reverb MSN Music
5. Severe weather forecast for Alabama  WVTM 13 News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3s2dxbm

April 10, 2021 at 03:14AM MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/37HEDLM

Hundreds of thousands of vaccine doses go unordered by states amid outbreaks, spurring calls for new approach - The Washington Post

Hundreds of thousands of vaccine doses go unordered by states amid outbreaks, spurring calls for new approach  The Washington Post

via Top stories - Google News https://ift.tt/3fX7Bhq

April 10, 2021 at 02:44AM MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.

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

April 09, 2021 at 10:51PM CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections

ORA and CDER agree to replace and/or withdraw CPGs in favor of using guidance or procedural documents, as appropriate per GGP regulations.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2YLit9p

April 09, 2021 at 10:51PM CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3dsGAhu

April 09, 2021 at 10:51PM CPG Sec. 160.500 Answering Inquiries on Status of Criminal Referrals

CPG Sec. 160.500 Answering Inquiries on Status of Criminal Referrals

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

April 09, 2021 at 10:51PM CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention

The agency has received many questions concerning the use of microfiche and/or microfilm systems in lieu of the retention of original records. This Compliance Policy Guide is based on a May 11, 1979 response to a request for an Advisory Opinion on this subject. (Docket Number 77A-0270).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3hlp3uo

April 09, 2021 at 10:51PM CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning

CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3dSp5YA

April 09, 2021 at 10:51PM CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation

CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation

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

April 09, 2021 at 10:51PM CPG Sec. 160.300 Requests for Records Under Section 703

CPG Sec. 160.300 Requests for Records Under Section 703

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3fe7Z7v

April 09, 2021 at 10:51PM CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling

CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/37mKfvf

April 09, 2021 at 10:51PM CPG Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance Activity

CPG Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance Activity

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

April 09, 2021 at 10:51PM CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis

CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis

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

April 09, 2021 at 10:51PM CPG Sec. 160.600 Payment of Expert Witnesses

CPG Sec. 160.600 Payment of Expert Witnesses

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3dTOwZz

April 09, 2021 at 07:33PM Moderna COVID-19 Vaccine

Information about the Moderna COVID-19 Vaccine

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3rlqM82

April 09, 2021 at 07:28PM Pfizer-BioNTech COVID-19 Vaccine

Information about the Pfizer-BioNTech COVID-19 vaccine

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3774pem

April 09, 2021 at 04:16PM Roster of the Vaccines and Related Biological Products Advisory Committee

This is the Roster of the Vaccines and Related Biological Products Advisory Committee

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2LdRQ7c

April 09, 2021 at 12:51PM Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2N7vN39

April 08, 2021 at 07:33PM Biological Product Deviation Reports Annual Summaries

Biological Product Deviation Reports Annual Summaries

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2zcY1nI

April 08, 2021 at 03:58PM Donate COVID-19 Plasma

If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Because you fought the infection, your plasma now contains COVID-19 antibodies.

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

Covid deaths reach 4,000 a day in Brazil, bringing hospitals to breaking point - NBC News

1. Covid deaths reach 4,000 a day in Brazil, bringing hospitals to breaking point  NBC News
2. Bolsonaro shrugs off criticism he is 'genocidal' as Brazil reports record 4,000 daily deaths  CNN
3. Brazil COVID-19 deaths on track to pass worst of US wave  New York Post
4. Brazil’s coronavirus death toll passes 4,000 a day for first time  The Guardian
5. With Daily Deaths Topping 4,000, Brazil’s COVID-19 Outbreak Is Out of Control  Slate
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/3usbwH6

April 07, 2021 at 02:40PM Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

Biosimilarity

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/36ThXZo

April 06, 2021 at 07:40PM Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates - 05/06/2021 - 05/06/2021

FDA is hosting a patient workshop on May 6, 2021. This workshop will bring together patients, caregivers, advocates, and other important stakeholders to discuss ways for patients and their advocates to work with FDA to help advance regenerative medicine for rare and genetic diseases.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3urQHeL

April 06, 2021 at 07:02PM 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/2XKPH9W

April 06, 2021 at 03:04PM 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/2ZNakT3

April 05, 2021 at 07:25PM Regenerative Medicine Advanced Therapy Designation

Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/2I3jrEY

April 02, 2021 at 02:24AM Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available

The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/3sNxl3A

April 01, 2021 at 08:52PM Administrative Guidances

This page lists Administrative Guidance documents.

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