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Regulatory Agenda › Final Guidance

McDermott Will & Emery

Preparing for 2025: Key Trends in FDA Guidance Agendas

McDermott Will & Emery on

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Future of the Medicare Drug Price Negotiation Program

Mintz - Health Care Viewpoints on

The Centers for Medicare and Medicaid Services (CMS) and pharmaceutical drug manufacturers are gearing up for the second round of negotiations as part of the Medicare Drug Price Negotiation Program (the Negotiation Program),...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

Akin Gump Strauss Hauer & Feld LLP on

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...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

A&O Shearman

Regulatory monitoring - December 2024

A&O Shearman on

1. Bank regulation - 1.1 PRUDENTIAL REGULATION - a) General - (i) International - FSB: Plenary December 2024 - Status: Final - The FSB has set out the outcomes of its Plenary that met on 3 and 4 December. Points of...more

Skadden, Arps, Slate, Meagher & Flom LLP

UK Adopts a New Consumer Duty: Key Implications for Financial Services Firms

Skadden, Arps, Slate, Meagher & Flom LLP on

The UK’s Financial Conduct Authority (FCA) published final guidance (FG22/5) and a policy statement (PS22/9) for the new consumer duty (Duty) on 27 July 2022. The main rules will come into force on 31 July 2023 for existing...more

Latham & Watkins LLP

BIS Issues Final Guidance on Stablecoin Regulation

Latham & Watkins LLP on

The global central bank cooperative body would bring stablecoins within the international standards for payment, clearing, and settlement systems....more

White & Case LLP

Crypto regulation: UK FCA clarifies regulatory perimeter – but leaves open questions over its tech neutrality

White & Case LLP on

On 31 July 2019 the UK Financial Conduct Authority (FCA) published final Guidance on the cryptoasset activities within its regulatory perimeter, in response to feedback on its January 2019 consultation paper and as trailed in...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2019 #2

Shook, Hardy & Bacon L.L.P. on

LEGISLATION, REGULATIONS & STANDARDS - CBD Banned from New York Restaurants, in Limbo in Idaho - New York City’s health department has reportedly ordered restaurants to stop serving products that contain cannabidiol...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

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