On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic. Here’s how it’s impacting some pharma and device firms.
Govzilla and Valisure Announce A Collaboration Focused on Creating A Platform For Evidence-Based Quality Scores For Drug Products
The new platform will use AI to generate quality scores based on a combination of public FDA reports and Valisure’s chemical analysis of on-market drug products.
Join Govzilla’s GMP Quality Expert Jerry Chapman for an informative 1-hour webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.
Govzilla announces the addition of Jane Wastl as Senior GMP Quality Expert to the Govzilla team.
Govzilla announces the addition of Jerry Chapman as Senior GMP Quality Expert to the Govzilla team.
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.
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.