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Regulatory Focus Articles RSS Feed 2.0
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...

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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...
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...
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.