Enforcement in Brief
This article was originally published in The Gold Sheet
Executive Summary
FDA and PIC/S inspection approaches are evolving, with FDA focusing on beta-lactams, CMOs and contract labs; and PIC/S working on inspection sharing, harmonizing on deficiencies, data integrity guidance and inspector training. Meanwhile, Dr Reddy’s gets warning letter, AstraZeneca sees EU noncompliance and four firms added to FDA’s drug GMP import alert.
You may also be interested in...
GSK Faces 'Profoundly Difficult' Penicillin Challenge, FDA Warning Letter Says
Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.