News & Analysis as of

Final Guidance

Mintz - Health Care Viewpoints

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

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

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

Foley Hoag LLP on

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Hogan Lovells

FDA Issues Final Guidance Setting Action Levels for Lead in Food Intended for Babies and Young Children

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled Action Levels for Lead in Processed Food Intended for Babies and Young Children (Final Guidance). The final action levels apply only to...more

Troutman Pepper Locke

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

Troutman Pepper Locke on

On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

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In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more

Akin Gump Strauss Hauer & Feld LLP

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

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

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

Alston & Bird on

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

BakerHostetler

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

BakerHostetler on

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

DLA Piper

Food and Beverage News and Trends - January 2025

DLA Piper on

FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary...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

Ervin Cohen & Jessup LLP

EEOC Issues Anticipated Final Guidance On Harassment Claims

The Equal Employment Opportunity Commission issued its long-awaited final guidance on harassment claims, which went into immediate effect....more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...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

McDermott+

FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

McDermott+ on

On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more

King & Spalding

FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions

King & Spalding on

On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” (the “2024 Final...more

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

Ropes & Gray LLP on

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes PCCP Guidance for AI-Enabled Medical Devices

Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of...more

Venable LLP

New Center for Veterinary Medicine Final Guidance: Will AAFCO Animal Feed Ingredient Definitions Continue to Be a Safe Harbor for...

Venable LLP on

The FDA Center for Veterinary Medicine released the Final Guidance for Industry today for its enforcement policy for AAFCO-defined animal feed ingredients. The big news is that FDA will no longer be reviewing the annual list...more

A&O Shearman

EU Final Guidance on Implementation of EU And National Sanctions

A&O Shearman on

The European Banking Authority has finalized two sets of guidelines setting common standards on the governance arrangements and the policies, procedures, and controls that financial institutions should have in place to be...more

Holland & Knight LLP

Treasury Department Issues Final Section 48D Guidance on CHIPS Act Semiconductor Tax Incentive

Holland & Knight LLP on

The Chips and Science Act of 2022 (CHIPS Act) added Section 48D to the Internal Revenue Code (Code) to incentivize the manufacture of semiconductors and semiconductor manufacturing equipment in the U.S. The credit is equal to...more

Troutman Pepper Locke

Preparing for the FDIC’s Final Enforceable Guidelines on Corporate Governance and Risk Management: State Nonmember Banks with...

Troutman Pepper Locke on

Over one year ago, on October 3, 2023, the Federal Deposit Insurance Corporation (FDIC) proposed supervisory guidelines that would establish standards for corporate governance and risk management for all state non-member...more

Hogan Lovells

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

Hogan Lovells on

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

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