FDA Warning Letter Review Suggests Aggressive Action Needed, Troy Says
This article was originally published in The Tan Sheet
Executive Summary
The FDA Office of Chief Counsel's review of warning and untitled letters suggests the agency should be taking more aggressive enforcement actions, Chief Counsel Daniel Troy suggested Feb. 21
You may also be interested in...
GMP Compliance – Not Investment – Impresses FDA, Chief Counsel Says
Manufacturers should not expect FDA to back off from GMP enforcement actions simply because firms have increased their investment in compliance, FDA Chief Counsel Daniel Troy said during a recent University of Georgia GMP conference
Warning Letter Review By FDA Chief Counsel’s Office Will Take Five Days
FDA's Office of Chief Counsel will have five working days to review warning letters that previously were sent directly to manufacturers from district offices
B.F. Ascher Halts Supplement/OTC Combo Sales Following FDA Warnings
B.F. Ascher has discontinued the sale of its Melagesic PM dietary supplement/OTC combination in response to FDA's decision the product is an unapproved new drug, according to the agency