FDA compliance actions
This article was originally published in The Gray Sheet
Executive Summary
Device center's Division of Bioresearch Monitoring issued 48 warning letters in FY 1994, up from 18 for FY 1993, according to Office of Compliance staffers. During FY 1994, the division also suspended five institutional review boards, initiated one automatic detention, and made 15 recommendations to the Office of Device Evaluation to reject or re-evaluate data as a result of BIMO's clinical investigation audits. For the entire device center, 117 warning letters were approved in FY 1994, slightly more than the FY 1993 total of 104, and 25 seizures were approved, down from 40 in the previous year. In addition, the center approved seven injunctions and five civil penalties actions during the last fiscal year, compared to 10 injunctions and six civil penalties in FY 1993
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.