An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such ...

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further ...

In practical effect, the CARES Act brought all ongoing, non-final OTC drug monograph proceedings to a close and made final FDA’s determination in “the most recently applicable proposal” under that ...

The act establishes a framework for collecting fees related to the regulation of OTC monograph drugs to support their review and oversight. The act allows the assessment and collection of fees from ...

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Please provide your email address to receive an email when new articles are posted on . Healio Clinical Guidance announced the launch of Drug Lookup, a free tool that provides quick access to drug ...