Medical Device Legal News with Sam Bernstein: Episode 11
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
Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more
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this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...more
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coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more
Over half a year after Congress passed a law modernizing the regulation of cosmetics in the U.S. (the Modernization of Cosmetics Regulation Act or "MoCRA"), the U.S. Food and Drug Administration ("FDA") has released draft...more
The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023.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
Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing more information on the newly...more
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the...more
Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products,” which clarifies the agency’s expectations regarding the...more
On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed...more
On August 7, 2023, FDA issued a draft guidance document entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“The Draft Guidance”), providing FDA’s current thoughts on the...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more