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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FDA announces day before due date that as it continues considering comments to a draft guidance on the requirement it published in October, the “document is not a binding document” and “the recommended … reporting date for 2020 data is not a requirement.”
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.