News & Analysis as of

Proposed Rules Comment Period Food and Drug Administration (FDA)

Benesch

CMS Proposes Overhaul of Skin Substitute Reimbursement Policy Beginning January 2026 - Implications for Providers, Manufacturers,...

Benesch on

On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more

Morrison & Foerster LLP

FDA and USDA Seek Comments on Defining Ultra-Processed Foods

On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published a joint Request for Information (RFI) to solicit information and data to help the agencies develop a...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

ArentFox Schiff

FDA and USDA Seek Public Input to Help Define ‘Ultra-Processed Foods’ as Part of MAHA Campaign

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On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”...more

Akin Gump Strauss Hauer & Feld LLP

FDA, HHS and USDA Serve Up Ultra-Processed Food RFI

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request...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

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...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

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

Troutman Pepper Locke on

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Troutman Pepper Locke

FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products

Troutman Pepper Locke on

On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more

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

Affordable Care Act Proposed Rule Would Broaden Access to Over-the-Counter Contraception Without Cost Sharing

Employer-sponsored health plans would be required to cover over-the-counter contraception, including condoms and emergency contraception, without a prescription and without cost sharing under newly proposed Affordable Care...more

McGlinchey Stafford

Rescheduling Marijuana FAQs: How Do I Submit Comments on DEA’s Proposed Rules?

McGlinchey Stafford on

On May 16, 2024, the U.S. Drug Enforcement Administration (DEA) released the proposed rule (Proposed Rule) to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA). The Office of Legal...more

Bradley Arant Boult Cummings LLP

Texas Regulators to Consider Changes to Consumable Hemp Program

The Texas Health and Human Services Commission, on behalf of the Texas Department of State Health Services, recently announced that it was accepting public comments to the current rules governing consumer hemp products in the...more

McDermott Will & Schulte

FDA Proposes Rule to Update Clinical Trial Data Monitoring

On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...more

Braumiller Law Group, PLLC

Hot Topics in International Trade - November 2023 - Any Comments on FDA’s New Proposed Rule on Prior Notice Regulations?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the Food and Drug Administration (FDA) to take additional measures for safeguarding the public against potential terrorist attacks on...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Goodwin

FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part I: Underpinnings of FDA’s Proposed Rule

Goodwin on

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). The proposed rule and policy are the latest in an over...more

Bass, Berry & Sims PLC

FDA Takes Definitive Step Toward the Regulation of LDTs

Bass, Berry & Sims PLC on

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Goodwin

FDA Proposes Phased Approach to Regulating Laboratory Developed Tests

Goodwin on

On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs). If enacted, the proposed...more

Goodwin

LDT Proposed Rule Remains Under OIRA Review

Goodwin on

Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more

Morgan Lewis - Well Done

Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods

FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more

Troutman Pepper Locke

FDA Proposes New Rules for Prescription Drug Labeling

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On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more

Hogan Lovells

FDA advances nutrition initiatives: dietary guidance statements and salt substitutes in standardized foods

Hogan Lovells on

FDA recently issued two nutrition-related initiatives regarding dietary guidance statements and the use of salt substitutes in standardized foods. The first initiative, a draft guidance, contains agency recommendations on the...more

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