FDA’s McMullen: No Bigger Waste Than Drug Shortages Due To Data Integrity

 
• By Anju Ghangurde

FDA officials highlight at a recent summit in India recurring issues around drug manufacturing compliance including microbial contamination and data integrity concerns but emphasize that the agency isn’t in a “gotcha” mode for companies.

From L-R: Shirish Belapure - Senior Technical Advisor, IPA; Rubina Bose, Deputy Drugs Controller India; Sarah McMullen, Country Director, India Office, US FDA; James Pound, Deputy Director Standards & Compliance, MHRA; Thomas Hecker, Inspector, Certification of Substances Department, EDQM

More from US FDA

More from Agency Leadership