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.
The second and final part of this report will cover the actions firms can take to prevent, identify, and remediate issues as well as summarizing the trends of data integrity failures.
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 evaluates data integrity deficiencies from CY2018 and presents the trends since CY2008.
We cover three GMP drug warning letters and a warning letter to a large CBD firm for misbranding and distribution of the unapproved new drug. FDA did not agree with the firm’s statement that the product was a dietary supplement.
GMP expert Barbara W. Unger reviews the Office of Generic Drugs’ 2018 Annual Report.
FDA published three drug warning letters this week, one of which was issued in April and one that found a firm to be shredding GMP documents.