Annual Report With Monthly Production Totals Added To OTC Monograph Drug Firms' To-Do List
Firms making drugs available in US without pre-market approval, including homeopathics, got another annual reporting requirement under CARES Act. “It's going to be a bit of a sea change for the industry, and they're going to need to be prepared for it,” says attorney Ann Begley.
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Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.
Decisions in US Circuit and District courts for District of Columba are on complaint by Rx drug firm MediNatura, but should resonate for OTC homeopathic firms as well as all businesses across the sector. MediNatura appealed district ruling rejecting request for injunction against FDA’s withdrawal of 1988 homeopathic CPG.
Products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.