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Filing Deadlines Food and Drug Administration (FDA)

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

ArentFox Schiff

Deadline to Register Cosmetic Facilities and List Cosmetic Products Fast Approaches

ArentFox Schiff on

Companies subject to the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) should take note that the deadline to register cosmetic facilities and list cosmetic products is fast approaching on July...more

Venable LLP

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

Venable LLP on

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

BCLP

Part 2 in MoCRA series: FDA guidance on facility registrations

BCLP on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is significantly changing regulation of the cosmetics industry in the U.S. For the first time, cosmetics manufacturers and brand owners will need to register...more

BCLP

FDA Issues Draft Guidance on Complying With MoCRA

BCLP on

The U.S. Food and Drug Administration has issued a draft guidance to assist companies submitting cosmetic product facility registrations and cosmetic product listings to the FDA in compliance with the Modernization of...more

Venable LLP

Prepare Now for the New FDA Requirements for Cosmetics Companies

Venable LLP on

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

King & Spalding

CMS Proposes New DMEPOS Coverage Policies and Payment Rates, and Seeks to Codify HCPCS Application, Benefit Category and Payment...

King & Spalding on

On November 4, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (the Proposed Rule) outlining proposals for the coverage and payment for durable medical equipment, prosthetics, orthotics, and...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Update #21

Leaders of Small Business Committee Reach Consensus on Bill to Extend PPP Loan Deadline, Senate Fails to Clear Measure by Unanimous Consent as Phase 4 Negotiations Likely to Dominate June - Bipartisan leaders of the Senate...more

American Conference Institute (ACI)

[Webinar] What New Dietary Ingredient Master Files Mean for Innovation & Compliance - May 27th, 1:00 pm - 2:00 pm EST

FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #5

Hogan Lovells on

In Washington: Vice President Mike Pence’s press secretary, Katie Miller, has tested positive for coronavirus.  This is the second case of White House staff testing positive since yesterday.  Miller is married to White House...more

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