POSTS

Post by FDAzilla | August 29, 2019

Gaining GMP Expertise: Govzilla Adds Jane Wastl as Senior GMP Quality Expert

Govzilla announces the addition of Jane Wastl as Senior GMP Quality Expert to the Govzilla team.

Post by FDAzilla |

Gaining GMP Expertise: Govzilla Adds Jerry Chapman as Senior GMP Quality Expert

Govzilla announces the addition of Jerry Chapman as Senior GMP Quality Expert to the Govzilla team.

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.

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.

Post by FDAzilla | July 2, 2019

Govzilla Speaking at KENX’s GMP University

When it comes to data integrity, audit recommendations, and corrective actions, the correct data analysis is essential for making informed, impactful decisions.

Post by FDAzilla | June 28, 2019

Access FDAzilla PRO for FREE!

We are excited to announce that we now offer a free version of our FDAzilla PRO platform!

Post by FDAzilla | May 3, 2019

New FDA Website Launched This Week

Have you clicked over to the FDA website recently? If so, you saw that the site has a whole new look and feel. After three years in the works, the US Food and Drug Administration (FDA) launched a more customer-centric website at FDA.gov that’s easier to search and view on all browser types and sizes.

One thing to note is you may find old links to the site no longer work, “Most URLs will change. Automatic redirects will be established, but users should update their bookmarks,” the FDA spokesperson said.

What does this mean for users of the FDAzilla platform and blog?