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Regulatory Requirements Public Comment Food and Drug Administration (FDA)

Hogan Lovells

HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

Hogan Lovells on

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more

Gardner Law

FDA Guidance for Labeling Plant-based Products

Gardner Law on

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding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

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...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

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

Foley Hoag LLP on

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

K&L Gates LLP

Health Care Triage: Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical...

K&L Gates LLP on

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more

Hogan Lovells

FDA Holds Summit on E-Commerce and Food Safety

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more

Mintz - Health Care Viewpoints

Are You a Medical Device Servicer or Remanufacturer? FDA’s New Guidance May Help…Or Not

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Brownstein Hyatt Farber Schreck

FDA Cracks Down on Companies Selling CBD Products

The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...more

Foley & Lardner LLP

Key Takeaways from USDA’s Interim Hemp Production Rule

Foley & Lardner LLP on

On October 31, 2019 the U.S. Department of Agriculture (USDA) published an Interim Final Rule (84 FR 58522) establishing the U.S. Domestic Hemp Production Program and outlining a regulatory framework for monitoring hemp...more

King & Spalding

USDA Issues Interim Final Rule to Establish Domestic Hemp Production Program and Approve State and Tribal Oversight Plans

King & Spalding on

Effective upon Publication, USDA’s Interim Final Rule Sets Forth One Important Part of the Regime for Marketing Hemp Products in the United States - This week, the U.S. Department of Agriculture (USDA) issued an interim...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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