This week FDA posted one letter to a fertility clinic, two to drug manufacturers, and one to a compounding pharmacy, and we cover those here.
Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship
After nearly 28 years at FDA—in review, inspection, and compliance positions—David Doleski, now Compliance Head for Biologics Quality Operations at Sanofi, provided his perspectives into how regulators think during his keynote presentation at the ISPE Aseptic Conference in early March 2020.
This week FDA posted three warning letters to drug firms, one to a device firm, and one to a compounding pharmacy. We cover these five here.
This week, FDA issued 42 warning letters to firms and individuals who distribute unapproved new drugs to prevent or treat COVID-19 infections, as well as two untitled letters and five warning letters to pharma/device firms.
No warning letters to drug firms were posted this week. One warning letter was issued to a device firm and one untitled letter was issued to a stem cell firm.
This report presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
Among the areas we cover, FDA posted one warning letter issued to a fertility clinic governed by the HCT/P regulations and one to a compounding pharmacy.