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New Guidance Compliance Food and Drug Administration (FDA)

Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

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Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

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On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

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

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

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CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

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On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Gardner Law

FDA Guidance for Labeling Plant-based Products

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The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...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

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

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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

Alston & Bird

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....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

Gardner Law

What the DOJ Looks For: Key Insights into Evaluating Your Compliance Program

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The Department of Justice's Criminal Division recently released an updated version of its Evaluation of Corporate Compliance Programs document (the "Guidance" or “ECCP”). This Guidance is designed to be a resource for...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more

McNees Wallace & Nurick LLC

The OIG Releases Updated General Compliance Program Guidance

As 2023 came to a close, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated General Compliance Program Guidance (GCPG) manual, which serves as a reference guide for...more

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Regulators Must Write Cloud-Specific Guidance

Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more

Foley Hoag LLP

Medicare Drug Price Negotiation Program Initial Guidance

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On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more

McDermott Will & Schulte

After Almost 25 Years, FTC Issues New Health Products Compliance Guidance

The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more

Hinch Newman LLP

Advertising Law Alert: FTC Announces New Health Products Compliance Guidance

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In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more

Venable LLP

FTC Announces Health Products Compliance Guidance

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On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more

Snell & Wilmer

Federal Agencies Issue Guidance After Dobbs Ruling

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In response to the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health and Human Services (“HHS”) Secretary Xavier Becerra directed HHS agencies to act within their power to...more

Haug Partners LLP

Understanding the FDA’s Medical Products Clinical Trial Guidance amidst COVID-19

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Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Holland & Knight LLP

Food and Beverage Law Update: October 2015

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Labor and Employment - Plaintiff Wage and Hour Lawsuits Continue to Climb - Wage and hour litigation has become what some call the new "workplace revolution." Data from the Federal Judicial Center indicates that...more

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