News & Analysis as of

Regulatory Agenda New Guidance Final Rules

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

Wiley Rein LLP on

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Hogan Lovells

FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Hogan Lovells on

On January 6, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Troutman Pepper Locke

FDIC and OCC Finalize New Guidelines on Bank Mergers

Troutman Pepper Locke on

Yesterday, both the Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency (OCC) finalized new guidelines regarding bank mergers. According to the agencies, these updates aim to enhance...more

Williams Mullen

Environmental Notes - March 2021

Williams Mullen on

Arguably, the Social Cost of Carbon (SCC) is one of our society’s most important numbers. The SCC is used in all climate decisions and will now be considered in all significant governmental decisions and federal actions. How...more

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