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Rulemaking Process › Food and Drug Administration (FDA) › Life Sciences

Latham & Watkins LLP

100 Days In: FDA Updates and Trends to Watch

Latham & Watkins LLP on

Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

Skadden, Arps, Slate, Meagher & Flom LLP on

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

Faegre Drinker Biddle & Reath LLP on

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

Polsinelli on

As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Health Care Compliance Association (HCCA) on

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

King & Spalding

Emerging Regulation, Enforcement, and Litigation Involving Ethylene Oxide, a Critical Substance for Sterilizing Medical Products...

King & Spalding on

Ethylene oxide (“EtO”), one of the most widely used and effective substances for sterilizing medical products and devices, has come under intense scrutiny by the Environmental Protection Agency (“EPA”), the Food and Drug...more

Hogan Lovells

New draft guidance on MR compatibility for medical devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

Hogan Lovells on

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

Hogan Lovells

Regulator proposes reducing requirements for radiation-emitting products

Hogan Lovells on

In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices. ...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

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Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

Morgan Lewis

FDA Active on the Device Front for Q1 2016

Morgan Lewis on

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

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