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Product Labels Manufacturers Draft Guidance

McDermott Will & Emery

FDA Seeks Comments on Updates to MoCRA Guidance on Registration, Listing of Cosmetic Product Facilities

McDermott Will & Emery on

On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...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FDA’s Draft Guidance on Cosmetics Registration and Listing: A Good Reminder of End-of-Year Deadlines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this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...more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Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings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coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more

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FDA Issues Draft Guidance on Facility Registration under MoCRA

The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023.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Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing more information on the newly...more

Morgan Lewis

A New Foundation: FDA Issues Draft Guidance On Mocra Cosmetic Registration, Listing Requirements Ahead Of December 29 Statutory...

Morgan Lewis on

The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the...more

Troutman Pepper Locke

FDA Issues Draft Guidance on Facilities ‎and Product Registration and Listing Under ‎MoCRA

Troutman Pepper Locke 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

Arnall Golden Gregory LLP

Sooner or Later, Everything Old is New Again: FDA Issues Draft Guidance Addressing Remanufacturing of Medical Devices

The Food and Drug Administration issued new draft guidance titled, “Remanufacturing of Medical Devices,” on June 17, 2021, with the goal of clarifying whether activities performed on medical devices are considered...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on

The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Hogan Lovells

EU Commission seeks feedback on implementing the new Market Surveillance Regulation

Hogan Lovells on

The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more

Arnall Golden Gregory LLP

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

Troutman Pepper Locke

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper Locke on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

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