RECENT POSTS

FOI Services Header Image
Post by FDAzilla | August 28, 2019

Upcoming Webinar: It’s Not All on the Web – Finding the FDA Information You Didn’t Know You Could Have

Join President of FOI Services, Marlene Bobka, for an informative 1-hour webinar about all things FOIA. Gain a deeper understanding of the internal workings of FDA and help prevent legal actions, financial penalties and other costly errors at your company.

WWL082719
Post by Barbara W. Unger | August 27, 2019

Week of August 18th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week, there were a total of five issued warning letters: three were issued to drug manufacturers, one to a compounding pharmacy, and one to a device manufacturer.  The first one issued to Deva Holdings addresses severe penicillin cross-contamination.

Office of Compliance
Post by Barbara W. Unger | August 22, 2019

Review of the Office of Compliance CY2018 Annual Report

GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER's Office of Compliance Annual Report for CY2018.

WWL082019
Post by Barbara W. Unger | August 20, 2019

Week of August 11th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter, and one in the food area that is a ‘first of its kind’.

AveXis
Post by FDAzilla | August 14, 2019

AveXis’s New Gene Therapy Approved but New Questions Are Raised

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.

WWL081319
Post by Barbara W. Unger | August 13, 2019

Week of August 4th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted seven warning letters this week, among which was one to a finish pharmaceutical manufacturer.  We cover that warning letter here.

DI Failures Part 2
Post by Barbara W. Unger | August 9, 2019

Part 2: Analysis of CY2018 FDA Warning Letters That Cite Data Integrity Failures

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.

WWL080619
Post by Barbara W. Unger | August 6, 2019

Week of July 28th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

DI Failures Feature
Post by Barbara W. Unger | August 1, 2019

Part 1: Analysis of CY2018 FDA Warning Letters That Cite Data Integrity Failures

GMP expert Barbara W. Unger evaluates data integrity deficiencies from CY2018 and presents the trends since CY2008.