News & Analysis as of

Risk Assessment Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

Bergeson & Campbell, P.C.

FDA Extends Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments

The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As...more

Bergeson & Campbell, P.C.

FDA Begins Public Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments 

The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Beveridge & Diamond PC

FDA Seeks Public Comment on Post-Market Chemical Review Prioritization Method

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released its draft post-market chemical review prioritization method for public comment. Public comments are due July 18, 2025....more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Holland & Knight LLP

Food and Chemical Update: FDA Unveils Data-Driven Assessment Tool to Rank Food Chemicals

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more

ArentFox Schiff

FDA Unveils a Tool for Prioritizing Food Chemicals for Post-Market Assessment

ArentFox Schiff on

On June 18, the US Food and Drug Administration (FDA) released for public comment a proposed method for ranking chemicals present in the food supply to determine which should be prioritized for post-market safety assessments....more

Morgan Lewis - Well Done

FDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients

On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more

Morrison & Foerster LLP

FDA Publishes Post-Market Assessment Tool to Rank Chemicals in Food Supply

On June 18, 2025, FDA published a proposed “Post-Market Assessment Prioritization Tool” to guide how the agency plans to rank and prioritize food chemicals under its enhanced post-market review process. FDA’s unveiling of...more

Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

Holland & Knight LLP on

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

ArentFox Schiff

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

ArentFox Schiff on

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2025

TSCA/FIFRA/TRI - EPA Receives TSCA Section 21 Petitions Seeking Reconsideration Of Exemption Conditions In Final Trichloroethylene Rule: The U.S. Environmental Protection Agency (EPA) recently updated its website to include...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Gardner Law

From Paper to Practice: Compliance Policies that Work

Gardner Law on

In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 24th - 27th, Chicago, IL

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

McDermott Will & Schulte

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 2nd - 4th, Orlando, FL

Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

ArentFox Schiff on

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

Akin Gump Strauss Hauer & Feld LLP

In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Alston & Bird

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

Alston & Bird on

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

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

King & Spalding on

On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

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