FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.
JUUL Labs recently received a first-of-its-kind warning letter from CTP. Learn more about the warning letter and what makes it unique.
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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.
After fifteen years of zero FDA enforcement activity, Immunomedics was hit hard not once, but twice in one month. The second punch was concerning enough to thrust them into the spotlight, causing their stock to be sold and their shares to plummet.
FDA issues the first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.