November 30, 2022 at 10:16PM FDA Approves First Fecal Microbiota Product

FDA approves the first fecal microbiota product, Rebyota. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for used after an individual has completed antibiotic treatment for recurrent CDI.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/bMCU2OF

November 30, 2022 at 08:12PM Biologics Electronic Reading Room (eFOI)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

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

Strong thunderstorms and tornadoes are predicted across parts of the South - NPR

1. Strong thunderstorms and tornadoes are predicted across parts of the South  NPR
2. Live: Storm Chasers Track Dangerous Severe Weather Outbreak in the South  FOX Weather
3. Significant Severe Weather Outbreak In South Threatens 25 Million  FOX Weather
4. A 'particularly dangerous situation' tornado watch has been issued for 3 southern states  CNN
5. Storms could spawn major tornadoes, floods in several states  FOX 2 St. Louis

via Top stories - Google News https://ift.tt/mofgR48

November 29, 2022 at 09:40PM COVID-19 Vaccines

FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

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

November 29, 2022 at 02:28PM Antimicrobial Resistance Information from FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

via Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda

Severe storm, tornado outbreak possible in Mississippi Valley, South - The Washington Post

1. Severe storm, tornado outbreak possible in Mississippi Valley, South  The Washington Post
2. Forecasters Warn of Tornado Threat Across the South  Yahoo! Voices
3. Tornado Outbreak Possible In The South | Weather.com  The Weather Channel
4. Significant tornadoes, damaging winds, and hail possible for the South on Tuesday  CNN
5. Memphis, Shelby Co. crews prepare for threat of severe storms  Action News 5
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/U2jrH0T

November 28, 2022 at 08:02PM KINRIX

Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/OM1C20P

November 25, 2022 at 10:44PM Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/SlUEV1b

'A significant severe-weather event will be likely' this week, meteorologists say - CNN

1. 'A significant severe-weather event will be likely' this week, meteorologists say  CNN
2. Severe Weather concerns this week.  ABC24 Memphis
3. Calm Days Today and Tuesday; Severe Risk Tues. Night - Alabama News  Alabama News Network
4. Discussing the potential for a severe weather outbreak on Tuesday November 29th 2022  KARK 4 News
5. Strong Storms Possible by Mid-Week  WHNT News 19
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/cLB8JKT

'A significant severe-weather event will be likely' this week, meteorologists say - CNN

1. 'A significant severe-weather event will be likely' this week, meteorologists say  CNN
2. Severe Weather concerns this week.  ABC24 Memphis
3. Arkansas to see strong severe storms Tuesday night  THV11.com KTHV
4. Discussing the potential for a severe weather outbreak on Tuesday November 29th 2022  KARK 4 News
5. Strong Storms Possible by Mid-Week  WHNT News 19

via Top stories - Google News https://ift.tt/cLB8JKT

'A significant severe-weather event will be likely' this week, meteorologists say - CNN

1. 'A significant severe-weather event will be likely' this week, meteorologists say  CNN
2. Discussing the potential for a severe weather outbreak on Tuesday November 29th 2022  KARK 4 News
3. Forecasters warn 'severe' weather front will spawn devastating tornadoes and damaging winds  Daily Mail
4. Severe weather 'outbreak' to impact 25 million people in southern US  USA TODAY
5. Arkansas Storm Team Weather Blog: Significant severe weather threat Tuesday  KARK

via Top stories - Google News https://ift.tt/cLB8JKT

'A significant severe-weather event will be likely' this week, meteorologists say - CNN

1. 'A significant severe-weather event will be likely' this week, meteorologists say  CNN
2. Discussing the potential for a severe weather outbreak on Tuesday November 29th 2022  KARK 4 News
3. Forecasters warn 'severe' weather front will spawn devastating tornadoes and damaging winds  Daily Mail
4. Severe storms predicted Tuesday could affect 25 million people in South  St. Louis Post-Dispatch
5. Arkansas Storm Team Weather Blog: Significant severe weather threat Tuesday  KARK
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/cLB8JKT

November 25, 2022 at 10:40PM Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies

Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies Draft Guidance for Industry, CBER, Biologics

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Zt8nIOs

November 25, 2022 at 07:18PM FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - 11/15/2022

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better understand patient perspectives on gene therapy products, including cell-mediated gene therapy.

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

November 25, 2022 at 04:23PM Section 8100: Communication

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

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/5SI7Gjq

China's Covid cases hit record as dissent grows over tough restrictions - CNN

1. China's Covid cases hit record as dissent grows over tough restrictions  CNN
2. China COVID numbers hit record, economic outlook darkens  Reuters
3. Mainland China's total daily Covid cases soar above Shanghai lockdown highs  CNBC
4. China Recovery Set Back by Record Covid Outbreak as Lockdowns Spread  The Wall Street Journal
5. China's COVID infections hit record as economic outlook darkens  Yahoo News

via Top stories - Google News https://ift.tt/8ywbn9E

China Covid Cases Hit Record, Topping Shanghai Omicron Outbreak - Bloomberg

1. China Covid Cases Hit Record, Topping Shanghai Omicron Outbreak  Bloomberg
2. China may have 'passed the point of no return' as Covid infections soar  CNBC
3. As China hits Covid high, move to ease measures meets containment push  South China Morning Post
4. Hutong Cat | The Chinese are fed up with Covid restrictions & they're showing it  Hindustan Times
5. China expands lockdowns as COVID-19 cases hit daily record  The Washington Post
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/cWYad82

November 22, 2022 at 10:16PM Approved Cellular and Gene Therapy Products

Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/qbas52D

November 22, 2022 at 05:12PM FDA Patient Listening Sessions

Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives.

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

Goldman Sachs Slashes Oil Price Forecast By $10 - OilPrice.com

1. Goldman Sachs Slashes Oil Price Forecast By $10  OilPrice.com
2. Oil prices fall around $1 to near 2-month lows as supply concerns ease  Yahoo News
3. World Business Watch: Oil prices dip to near 2-month lows | World Latest English News | WION  WION
4. Goldman cuts oil forecast on 'lack of clarity' over G-7 Russia oil price cap, China Covid outbreaks  CNBC
5. Oil rebounds from early plunge after Saudis deny OPEC+ output report  Yahoo Finance

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

Goldman Sachs Slashes Oil Price Forecast By $10 - OilPrice.com

1. Goldman Sachs Slashes Oil Price Forecast By $10  OilPrice.com
2. Oil prices fall around $1 to near 2-month lows as supply concerns ease  Yahoo News
3. Goldman cuts oil forecast on 'lack of clarity' over G-7 Russia oil price cap, China Covid outbreaks  CNBC
4. World Business Watch: Oil prices dip to near 2-month lows | World Latest English News | WION  WION
5. Oil prices rebound from early dive as reports vary on OPEC+ output  Yahoo Finance
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/DWk8jAy

November 21, 2022 at 07:33PM Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, Procedural

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/S9smWiF

Stocks Drop on China Covid Worries; Dollar Rises: Markets Wrap - Yahoo Finance

1. Stocks Drop on China Covid Worries; Dollar Rises: Markets Wrap  Yahoo Finance
2. Hong Kong stocks fall 2% on Covid fears; China keeps benchmark lending rates on hold  CNBC
3. Live news updates: China and Hong Kong stocks drop as Covid curbs spook investors  Financial Times
4. Asia shares, oil prices skid on China COVID outbreaks  Yahoo Finance
5. World stocks tumble on Chinese COVID outbreaks  Reuters
6. View Full Coverage on Google News

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

November 18, 2022 at 05:21PM 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/OL31oBS

November 18, 2022 at 05:20PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/pA16BH2

November 18, 2022 at 04:38PM Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial

This is the guidance Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/g8ujrC7

November 16, 2022 at 07:42PM 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/8CJ7THV

November 15, 2022 at 08:43PM 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/GDxymKg

November 15, 2022 at 06:52PM 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/FpTQVLE

November 14, 2022 at 10:24PM INFANRIX

Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/80Yc2Rq

November 14, 2022 at 09:57PM 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/uQ2PZtO

November 14, 2022 at 07:26PM Pfizer-BioNTech COVID-19 Vaccines

Information about the Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Vins06F

Cruise ship with 800 Covid cases docks in Sydney - BBC

1. Cruise ship with 800 Covid cases docks in Sydney  BBC
2. Majestic Princess cruise docks in Sydney with 800 covid cases  The Washington Post
3. Cruise Ship Docks in Sydney With 800 COVID Cases On Board  The Daily Beast
4. Princess cruise ship with at least 800 positive COVID-19 cases docks in Australia  USA TODAY
5. Cruise ship docks in Sydney after 800 people on board infected by COVID outbreak  Yahoo News
6. View Full Coverage on Google News

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

Chinese are criticizing zero-Covid — in language censors don't seem to understand - CNN

1. Chinese are criticizing zero-Covid — in language censors don't seem to understand  CNN
2. China slightly relaxes quarantine rules, shutdowns of cities and factories continue | DW News  DW News
3. China Eases Zero-Covid Rules as Economic Toll and Frustrations Mount  The Wall Street Journal
4. China won't relax COVID policies but will keep improving them - govt expert  Reuters
5. Beijing Steps Up Covid Testing, Restrictions To Contain Outbreak  NBC News
6. View Full Coverage on Google News

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

Covid outbreak worsens in southern Chinese city of Guangzhou - CNBC

1. Covid outbreak worsens in southern Chinese city of Guangzhou  CNBC
2. China reports 10,729 new COVID cases for Nov 10 vs 9,005 a day earlier  Yahoo News
3. China's zero-Covid policy under pressure as infections rise in major cities  South China Morning Post
4. China's COVID curbs intensify as cases surge to highest since Shanghai lockdown  Reuters
5. China reports 10,000 new virus cases, capital closes parks  San Francisco Chronicle

via Top stories - Google News https://ift.tt/9gM3FDW

November 10, 2022 at 05:51PM Vaccines, Blood & Biologics

From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/otOH9Wq

Misinformation hampers Uganda’s battle against new outbreak of Ebola - The Guardian

1. Misinformation hampers Uganda’s battle against new outbreak of Ebola  The Guardian
2. Uganda closes schools early to try to contain Ebola outbreak : Goats and Soda  NPR
3. Uganda Struggles to Contain Its Second-Deadliest Ebola Outbreak  The Wall Street Journal
4. WATCH | 'Death every day': Fear and fortitude in Uganda's Ebola epicentre  News24
5. WHO Emergency Appeal: Ebola Disease Outbreak in Uganda (October 2022 - March 2023) - Uganda  ReliefWeb
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/w7YMtxT

China's manufacturing hub Guangzhou locks down millions as Covid outbreak widens - CNN

1. China's manufacturing hub Guangzhou locks down millions as Covid outbreak widens  CNN
2. Beijing reports 32 symptomatic and 48 asymptomatic Covid-19 cases for Tuesday | Latest English News  WION
3. Covid outbreak worsens in southern Chinese city of Guangzhou  CNBC
4. China's Guangzhou brings back mass testing to fight city's worst COVID outbreak | The World  ABC News (Australia)
5. China’s zero-Covid policy under growing strain as cases continue to spread  South China Morning Post
6. View Full Coverage on Google News

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

Misinformation hampers Uganda’s battle against new outbreak of Ebola - The Guardian

1. Misinformation hampers Uganda’s battle against new outbreak of Ebola  The Guardian
2. Uganda Struggles to Contain Its Second-Deadliest Ebola Outbreak  The Wall Street Journal
3. Uganda to close schools early after eight children die of Ebola  Al Jazeera English
4. Uganda shortens school term by two weeks to curb Ebola  Reuters
5. 'Death Every Day': Fear & Fortitude in Uganda's Ebola Epicentre  News18
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/w7YMtxT

Deadly listeria outbreak in 6 states linked to deli meat and cheese - CNN

1. Deadly listeria outbreak in 6 states linked to deli meat and cheese  CNN
2. Listeria outbreak has been linked to deli meat  CBS Boston
3. C.D.C. Links Deadly Listeria Outbreak to Deli Meats and Cheeses  The New York Times
4. 1 dead, over a dozen sick from outbreak tied to deli meat  WTOP
5. Seven people in New York infected with listeria outbreak strain  NEWS10 ABC

via Top stories - Google News https://ift.tt/DHOWu49

Ebola outbreak projected to surge as response repeats mistakes of Wuhan - The Telegraph

1. Ebola outbreak projected to surge as response repeats mistakes of Wuhan  The Telegraph
2. Uganda to close schools early after eight children die of Ebola  Al Jazeera English
3. Uganda Struggles to Contain Its Second-Deadliest Ebola Outbreak  The Wall Street Journal
4. OPINION | Ebola outbreak: Ending healthcare corruption key to saving lives and containing spread  News24
5. Uganda shortens school term by two weeks to curb Ebola  Reuters
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/YkEM7Fd

November 07, 2022 at 10:10PM Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

List of Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) products

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

November 07, 2022 at 03:54PM Consumer Updates

Science-based health and safety information you can trust.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/6QEyVkX

Apple warns of lower iPhone shipments as COVID curbs hobble China plant - Reuters

1. Apple warns of lower iPhone shipments as COVID curbs hobble China plant  Reuters
2. China Covid Live | China's Covid Outbreak Hits Apple iphone Production | World News  MIRROR NOW
3. Apple Cuts IPhone Shipments Outlook on China Lockdowns  Bloomberg Markets and Finance
4. Apple warns Covid restrictions in China are hurting iPhone production  CNBC
5. Covid Hits Apple, Meta Layoffs, Crypto Bustup - What's Moving Markets By Investing.com  Investing.com
6. View Full Coverage on Google News

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

Apple warns of lower iPhone shipments as COVID curbs hobble China plant - Reuters

1. Apple warns of lower iPhone shipments as COVID curbs hobble China plant  Reuters
2. China Covid Live | China's Covid Outbreak Hits Apple iphone Production | World News  MIRROR NOW
3. Apple Cuts IPhone Shipments Outlook on China Lockdowns  Bloomberg Markets and Finance
4. Apple warns Covid restrictions in China are hurting iPhone production  CNBC
5. WION Business News | Apple warns of hit to iPhone shipments due to covid-19 restrictions at Foxconn  WION

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

Apple warns of hit to iPhone shipments from China COVID disruption - Reuters

1. Apple warns of hit to iPhone shipments from China COVID disruption  Reuters
2. China Covid Live | China's Covid Outbreak Hits Apple iphone Production | World News  MIRROR NOW
3. Apple Cuts IPhone Shipments Outlook on China Lockdowns  Bloomberg Markets and Finance
4. Apple warns Covid restrictions in China are hurting iPhone production  CNBC
5. WION Business News | Apple warns of hit to iPhone shipments due to covid-19 restrictions at Foxconn  WION
6. View Full Coverage on Google News

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

November 04, 2022 at 05:31PM Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Testing HCT/P Donors for Relevant Communicable Diseases

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Sdj3Or1

November 04, 2022 at 04:09PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/07u5XcZ

November 03, 2022 at 05:08PM Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere

For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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

November 03, 2022 at 03:41PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/Eay1f6C

November 02, 2022 at 08:21PM Pfizer-BioNTech COVID-19 Vaccines

Information about the Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized.

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

November 02, 2022 at 11:11PM Biologics Electronic Reading Room (eFOI)

The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/nN7Hjbe

November 02, 2022 at 11:08PM DG Gel Card 125445, 125449, 125450 - 125457

Product approval information is for:
•DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 A/B/D card is for the determination of human A, B and D antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse grouping, and D and Kell antigens on the surface of red blood cells in human blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells in two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test in human blood samples. This assay does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components.

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

November 02, 2022 at 08:38PM 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/7aX82d1

November 02, 2022 at 07:58PM Boostrix

Boostrix is a product approval indicated for Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 years of age and older

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/rpfFX7C

China Covid News: Beijing Locks Down Area Around Foxconn's 'IPhone City' Plant - Bloomberg

1. China Covid News: Beijing Locks Down Area Around Foxconn's 'IPhone City' Plant  Bloomberg
2. Workers flee China's biggest iPhone factory over Covid outbreak  CNN
3. WION Business News | China: Foxconn plant to increase bonuses if workers remain at the plant  WION
4. Xi's Covid Zero Is Killing China's iPhone Advantage  Bloomberg
5. China imposes COVID lockdown on area around iPhone factory  DW (English)
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/pZsGI7h

After Workers Flee, China iPhone Factory Offers Bonuses For Those Who Stay - NDTV

1. After Workers Flee, China iPhone Factory Offers Bonuses For Those Who Stay  NDTV
2. Workers flee China's biggest iPhone factory over Covid outbreak  CNN
3. Apple iPhone maker Foxconn slams 'maliciously edited' video that claims Covid deaths at China plant  CNBC
4. Xi's Covid Zero Is Killing China's iPhone Advantage  Bloomberg
5. Workers filmed fleeing major iPhone factory in China  Yahoo News
6. View Full Coverage on Google News

via Top stories - Google News https://ift.tt/Bo0dmO6