Resources

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 […]

FDA’s Center for Biologics Evaluation and Research (CBER) is overcoming daunting challenges in its enforcement of laws and regulations in the area of human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are being sold without the required FDA approval. While some companies are submitting applications to CBER seeking agency approval for marketing HCT/Ps, […]

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 presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013. The data presented for FY2019, ending September […]

In March, FDA posted five Form 483s to pharma firms and eleven to compounding/outsourcing facilities.The receiving pharma firms include two Biocon facilities, Immunomedics, Shilpa Medicare, and Dr. Reddy’s. [NOTE: Are you interested in learning more about observations with specific industry keywords? Get your FREE 483 Observation Report and you can quickly determine who has been hit with the […]

In the third report from December’s FDLI Enforcement, Litigation, and Compliance Conference, CDRH’s Associate Director for Compliance and Quality Erin Keith explains the Center’s completely revamped organization structure that was finalized late last Fall, its progress on international harmonization efforts, and the changing face of its compliance program. Did you know that CDRH no longer […]

FDA is halting domestic pharma inspections based on a recent article from RAPS.Shortly after the RAPS article published, the FDA announced they have temporarily postponed domestic routine surveillance inspections until such time as it is safe for them and the companies they inspect to resume.It’s telling that they didn’t put a re-evaluation date on this […]