Resources

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology, and medical device firms.  Repercussions have included new products not being approved, rescinded approval of products on the market, closure of manufacturing plants, massive product recalls, FDA import alerts, and drug shortages. At the same time, data is proving crucial to advancing […]

Highlights of FDA’s Center for Veterinary Medicine (CVM) activities in FY 2020 include: Releasing a draft guidance for industry on Compounding Animal Drugs from Bulk Drug SubstancesManaging animal drug shortages, implementing a new system that enables U.S. exporters of animal food, drugs, and devices to apply for and obtain various types of export certificates onlineCompleting […]

Warning letter enforcement was sparse again this week—many warning letters to firms promoting COVID diagnostics or treatments, that continues unabated. FDA posted one warning letter to an OTC pharmaceutical firm, but none to device, pharmacy, or outsourcing firms. CBER issued one untitled letter to a firm that markets cellular products from the umbilical cord or […]

FDA’s Quality Metrics Initiative, announced in April 2013 to help promote “quality-driven corporate culture” in drug and biologics manufacturing, has been slow in coming to fruition. However, itsQuality Metrics Site Visit and Feedback Programs that began in earnest in 2019 may help breathe life back into that effort. Find out more about what participants in […]

The FDA continued to issue warning letters to firms that distribute unapproved products for the prevention and treatment of COVID-19 infections. No warning letters were issued to drug manufacturers or compounding pharmacies, but the FDA did issue the following: Two untitled letters issued by CBER to firms distributing cell-based products. Two warning letters issued to […]

Over the years, the Redica blog (formerly Govzilla) has published over 725 articles covering a breadth of topics including: Trends & Analysis: Reports on key industry issues by our GxP ExpertsConference Spotlight: Updates from Jerry ChapmanEnforcement: Posts on Warning Letters, 483s, etc. And, more. To serve as a resource for you and your company and […]

FDA granted emergency use authorizations (EUA) for two therapeutic drugs to treat COVID-19 infections for use under specific conditions: On March 28, 2020 one was granted for chloroquine phosphate and hydroxychloroquine sulfateOn May 1, 2020 an emergency use authorization was granted for Remdesivir The EUA for the chloroquine products includes a waiver of the requirement […]

Fiscal Year (FY) 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article is Part 2 of a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013. The data presented […]