More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.
The majority of last year’s 110 drug GMP warning letters, 56, went to compounding pharmacies, including 21 to registered outsourcing facilities.
That’s more than twice the number of warning letters FDA sent pharmacies in fiscal year 2015, but just 51% of...
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
