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Regulatory Oversight Final Rules Food and Drug Administration (FDA)

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Bass, Berry & Sims PLC

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

Alston & Bird

EPA Finalizes Amendments to Air Toxics Standards for Ethylene Oxide Commercial Sterilizers

Alston & Bird on

Our Environment, Land Use & Natural Resources Group reviews the Environmental Protection Agency’s announcement of final amendments to the air toxics standards for ethylene oxide (EtO) commercial sterilizers....more

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

Foley Hoag LLP

New Intended Use Rule Finalized

Foley Hoag LLP on

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

FDA Issues Final Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

Hogan Lovells on

The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more

Perkins Coie

Industry Insights: FDA Sends First Warning Letter Under Recent Rule Regarding Imported Food

Perkins Coie on

The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign...more

Hogan Lovells

Nutrition Labeling Implementation Update – FDA Issues Technical Amendments to Final Rule

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The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when...more

Hogan Lovells

FDA Finalizes Extension of Compliance Date for Nutrition Labeling Final Rules

Hogan Lovells on

The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and...more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

Hogan Lovells on

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

Holland & Knight LLP

Food and Beverage Law Update: December 2016

Holland & Knight LLP on

Overtime Rules Enjoined Nationwide - In State of Nev. v. U.S. Dep't of Labor Case No. 4:16-cv-00731-ALM, 2016 WL 6879615 (E.D. Tex. Nov. 22, 2016), a Texas district court enjoined nationwide the Department of Labor's...more

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