US Pandemic Relief Package Delivers OTC Industry Regulatory Wishes, Supplement Business Hopes
It’s unlikely any industry stakeholder or FDA official expected a bill providing emergency economic relief to consumers, industries and health care services and facilities in response to a pandemic, including extensive support opportunities for small businesses, would be the vehicle that delivers on both of the industry’s congressional wishes. The supplement industry also looks for help in CARES Act.
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Expiration dates in HHS’ final SUNSET rule exclude OTC drugs after CCHPA and other groups argue the rule would create more problems than it would solve. But dietary supplement regulations are subject to the rule.
Rates published in December for FY2021 monograph user fee program prompted immediate questions and opposition. HHS says fee schedule is being withdrawn because the document “was issued without approval of the Secretary.”
The FDA says the new OTC monograph drug user-fee program (OMUFA) will provide additional resources needed to support the streamlined regulatory activities described by OTC drug reform legislation enacted in March 2020.