US FDA's Review Of Records Submitted By Foreign OTC Drug Firms Reveals GMP Problems
Turkish firm Gulsah Uretim Kozmetik Sanayi Anonim Sirketi is latest OTC manufacturer warned GMP violations based on records submitted in response to requests CDER submitted in March and April 2020.
You may also be interested in...
Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent Covid-19, the disease caused by the virus, and breakthrough products such as cancer treatments.
FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.
From intranasal corticosteroids to a lice treatment, and from an addition to the OTC PPI market to the first nonprescription acne drug reaching the market through an NDA, US OTC switches in the past 10 years, since FDA began considering widening switch opportunities, haven’t lacked for variety.