FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency(COVID-19) on March 19, 2020, and subsequently updated the guidance severaltimes, most recently on August 7, 2020. This guidance communicates...
It's been several years since COVID-19 vaccines from Pfizer and Moderna jumped to the top of the pharma industry's sales charts, displacing longtime stalwarts with unprecedented sales. But, as 2023 featured major patent expirations, the rise of weight loss drugs and other new dy...
1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). 1.企业未能进行至少一项检验以核实药品每种原辅料的成分(21 CFR 211.84(d)(1))。 Your response to our request for records and other information under section...
Before the public health emergency (PHE) declaration for the COVID-19 pandemic expired, the FDA evaluated the guidance documents created during the pandemic to determine if they should expire or continue past the PHE declaration expiration.2 Through this evaluation, the FDA determined t...
The agency attributed the shortages to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays. As of the May 2023 expiration of the COVID-19 public health emergency, theFDA no longer requires medical device manufacturers to report product shortages,...