FDA Law Blog

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

Manufacturing 105

Manufacturing Management IT Medical 105

FDA Law Blog

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.” 331(f)).

Management 113

Management IT Manufacturing Provider 113

FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96