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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

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

Prepare Now for the New FDA Requirements for Cosmetics Companies

Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

FDA Infant Formula Updates: New Labeling Guidance, Call for Enhanced Safety Measures, and Draft Protein Efficiency Ratio Testing

Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA). In total, these actions reflect FDA's dedication of resources to the infant formula industry....more

FDA Implements New Ingredient Directory

On March 6, 2023 in a Constituent Update, the FDA announced the establishment of its new Dietary Supplement Ingredient Directory, created in an effort "to help manufacturers, retailers, and consumers of dietary supplements...more

[Webinar] 2022 in Review and Preparing for 2023 at the FDA - December 14th, 2:00 pm - 2:30 pm ET

Join us on December 14 for a webinar providing a 2022 FDA year-in-review, with a crystal ball look into 2023. Venable Partners Claudia Lewis and Todd Harrison will discuss myriad topics, including a recap of major issues...more

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