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.
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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.
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?