Cares Act Fda 2024. Under the cares act, manufacturers of otc drugs could obtain 18 months of market exclusivity for their products, which could spur otc drug innovation. This guidance describes the process that should be used for reporting information under section 510(j)(3) by each person who registers with fda under section 510.
The cares act passed on 27 march 2020, requires each drug establishment registrant to report annual amounts of drugs that were manufactured, prepared, propagated,. On october 21, 2024, the alliance for natural health usa (“anh”), and meditrend inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry.