Melanie English

Venable LLP

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Latest Posts › Food and Drug Administration (FDA)

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The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

5/9/2024 / Advertising , Direct to Consumer Sales , Final Guidance , Final Rules , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Launches Cosmetics Direct, Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products Under...

Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more

12/29/2023 / Cosmetics , Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , Personal Care Products

FDA Delays Enforcement of MoCRA's Registration and Listing Requirements for Six Months

On November 8, 2023, the United States Food and Drug Administration (FDA or agency) announced it does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing under...more

11/17/2023 / Cosmetics , Enforcement , Filing Deadlines , Food and Drug Administration (FDA) , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , PFAS , Product Labels , Registration Requirement , Relief Measures

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