News & Analysis as of

Manufacturers Draft Guidance Product Packaging

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

Shook, Hardy & Bacon L.L.P.

FDA Takes Steps to Implement MoCRA

In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law in December 2022. The law requires cosmetic manufacturers...more

Beveridge & Diamond PC

MoCRA Update for Starting the Year Off Right

Beveridge & Diamond PC on

Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more

Kelley Drye & Warren LLP

FDA’s Draft Guidance on Cosmetics Registration and Listing: A Good Reminder of End-of-Year Deadlines

Earlier this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...more

Jones Day

Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings

Jones Day on

Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more

BakerHostetler

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

BakerHostetler on

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more

Bergeson & Campbell, P.C.

FDA Issues Draft Guidance on Facility Registration under MoCRA

The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023. The...more

Beveridge & Diamond PC

Cosmetic Product Registration and Listing Under MoCRA Comes Closer

Beveridge & Diamond PC on

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing more information on the newly...more

Locke Lord LLP

FDA Issues Draft Guidance on Facilities ‎and Product Registration and Listing Under ‎MoCRA

Locke Lord LLP on

On August 7, 2023, FDA issued a draft guidance document entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“The Draft Guidance”), providing FDA’s current thoughts on the...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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