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This Week at FDA: Pediatric use for Lilly’s COVID mAbs; Will Woodcock stay on?
03 December 2021
Welcome to month two of our weekly digest of regulatory news from the US Food and Drug Administration (FDA) and other corners of the health care product world. This week saw the expansion of Eli Lilly’s emergency use authorization (EUA) for two of...

Latest News

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COVID-19 vaccine tracker
03 December 2021
Updated 03 December with new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Bharat Biotech, Shifa Pharmed Industrial Group, and the first authorization of the vaccine f...
FDA expands eSTAR filing to de novo devices, IVDs
02 December 2021
US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kicked off in...
FDA announces FY 2022 GDUFA science and research priorities
02 December 2021
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs.

Latest Features

For Authors | ALL

Recent FDA approvals of drugs and biologics for childrenMember only

22 November 2021

The RACE is on: Opportunities in pediatric oncology product developmentMember only

19 November 2021

Global pediatric development: Challenges, potential solutions, and opportunitiesMember only

15 November 2021

 

RF Quarterly

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RF Quarterly, October 2021: Quality and compliance

04 October 2021

Data integrity and compliance with GxP: A pragmatic approachMember only

04 October 2021

Current good manufacturing practices and quality system designMember only

04 October 2021

  RECON
Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron

02 December 2021

Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate

01 December 2021

  ROUNDUPS
Euro Roundup: EMA chief calls for extra staff to handle growing workload

02 December 2021

FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor

01 December 2021