Webinars
Sign up for compounding and Compounding Quality Center of Excellence emailsThe FDA Compounding Quality Center of Excellence offers free recorded webinars to provide information on current good manufacturing practice standards, inspections and policies.Recorded...Nitrosamines in Rifampin and Rifapentine
[8/26/2020] These are antibacterial drugs used to treat tuberculosis; rifampin is also used to treat or prevent other serious infections. Patients taking rifampin or rifapentine should continue taking their current medicine and consult with their health care...FDA Updates and Press Announcements on Nitrosamine in in Varenicline
[7/02/2021] FDA is alerting patients and health care professionals to Pfizer’s voluntary recall of nine lots of the smoking cessation drug, varenicline (brand name Chantix), to the warehouse level. The company is recalling varenicline because it may contain levels of...FDA Helps Create Transparency and Value for Complex Generics
By Robert Lionberger, PhD, Director of the Office of Research and Standards in CDER’s Office of Generic Drugs Robert Lionberger Advancing complex generic drug development is an important part of FDA’s goal to help make sure patients have access to a broad range of...All Drug Purchases Are
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