Resources

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 […]

When early signs of a potential pandemic appeared and national border closings became a distinct possibility, many big pharma companies mobilized to move medicines from their warehouses into local warehouses in countries around the world to ensure that their patients in those countries would have access to the medicines they need when they need them. […]

Practices to mitigate the spread of COVID-19 have begun. Many people in pharma and biotech companies are working from home, and on-site staff is often severely limited to those performing business-critical activities. A serious concern of many is the security of their supply chain based on its complexity and global nature. We have already seen this play […]

Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes.  FDA also posted one issued to a drug manufacturer and one to a clinical investigator. We cover the latter two below. And, the Cipla warning letter we referenced last week has not been posted yet. […]

This is the second report from the Food and Drug Law Institute (FDLI) conference in December 2019. The first one, published in two parts, covered the Department of Justice (DOJ) activities in the CGMP compliance space during 2019. This article focuses on Center for Drug Evaluation and Research (CDER) activities in 2019. In FY 2019, […]

In February, FDA posted four Form 483s and one untitled letter to compounding/outsourcing facilities.Also posted were three Form 483s to firms in India: Aurobindo, Lupin Limited, and Dr. Reddy’s.We cover these below. And, we reviewed the FDAzilla Store to see which 483s were most-purchased and trending during February. 483s Posted Aurobindo Unit VII The inspection […]