FDA issued a particularly harsh press release on August 6, 2019 addressing the data accuracy issues with the BLA for the gene therapy product, Zolgensma, which was approved by FDA on May 24, 2019. It seems the FDA is using them, and more importantly their parent company Novartis, as an example of what not to do.
FDA posted seven warning letters this week, among which was one to a finish pharmaceutical manufacturer. We cover that warning letter here.
FDA posted five warning letters this week although none are drug or device GMP warning letters. However, two warning letters that we cover here were identified as posted on July 23rd. For any of you who also follow warning letters closely, be cautious about putting too much faith in FDA’s posting dates for the warning letters.
GMP expert Barbara W. Unger provides her assessment of CDER’s State of Pharmaceutical Quality Report.
A surprisingly busy week for enforcement considering the federal holiday. Warning letter enforcement includes five drug warning letters published this week, two of which were sent to API re-packagers, and one to a compounding pharmacy.
Three warning letters were posted this week in the areas we cover: two for drugs and one for device GMP violations. Akorn also announced that they received a warning letter but it has not yet been published.