News & Analysis as of

Public Health Government Agencies Regulatory Requirements

McDermott Will & Schulte

A need for speed: FDA piloting voucher program to expedite drug review

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Hogan Lovells

FDA and USDA Seek Feedback on Defining “Ultra-Processed Foods”

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On July 24, 2025, the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) issued a joint request for information (RFI) to gather information and data to help the agencies develop a uniform definition...more

Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

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On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Stikeman Elliott LLP

Canada’s Drug Agency Launches Public Consultation on Proposed List of Essential Prescription Drugs and Related Products

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On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...more

MG+M The Law Firm

Sewage Sludge and Wastewater Treatment Plants Identified as Key Sources of PFAS Pollution

MG+M The Law Firm on

New research suggests that sewage sludge and wastewater treatment plants are major sources of per- and polyfluoroalkyl substances (PFAS) pollution. Waterkeeper Alliance, in partnership with local Waterkeeper groups and the...more

Smart & Biggar

CDA opens consultation on proposed list of drugs to inform development of national formulary

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On June 19, 2025, Canada’s Drug Agency (CDA) opened a public consultation on a proposed process for preparing a list of essential prescription drugs and related products. As required by the Pharmacare Act, the CDA must...more

MG+M The Law Firm

Tustin, California's New State-Funded Water Treatment System to Eliminate PFAS From Drinking Water

MG+M The Law Firm on

Facing federal government plans to weaken regulation of “forever chemicals” in drinking water, Tustin’s Governor, Gavin Newsom, announced the city received a new, state-funded water treatment system designed to remove per-...more

Allen Matkins

Air District Asbestos Rule Will Affect Demolition Activities for Facilities Damaged by the Los Angeles Wildfires

Allen Matkins on

Owners and operators of facilities damaged or destroyed by the recent Los Angeles-area wildfires should be aware of the risks posed by toxic contaminant releases during cleanup and, in particular, the regulatory requirements...more

Lathrop GPM

Trump Executive Order Restricts Funding for “Dangerous Gain-of-Function Research”

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On May 5, the Trump administration issued Executive Order 14292, “Improving the Safety and Security of Biological Research,” which effectively ends federal funding for “dangerous gain-of-function research” and other life...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Community Air Monitoring and Notification System Task Force: Louisiana Department of Environmental Quality Releases Final Report

The Louisiana Department of Environmental Quality (“LDEQ”) issued an April 28th news release announcing the release of the Final Report on the Community Air Monitoring and Notification System Task Force (“Task Force”)....more

Downey Brand LLP

Court Overturns Prop 65 Acrylamide Warning

Downey Brand LLP on

On May 2, a federal district court in Sacramento permanently enjoined the Prop 65 warning for acrylamide in food, finding it to be unconstitutional. At issue in the case, California Chamber of Commerce v. Bonta (E.D. Cal. No....more

Mitchell, Williams, Selig, Gates & Woodyard,...

FY 2026 Federal Grant Funding for State and Local Clean Air Agencies: National Association of Clean Air Agencies Recommendations

The National Association of Clean Air Agencies (“NACAA”) issued a document titled: Recommendations for FY 2026 Federal Grant Funding for State and Local Clean Air Agencies (“Recommendations”)....more

Wenning Environmental

Will damage, impact, and risk assessment get “DOGE’d”?

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President Trump’s January 31, 2025, executive order (EO), Unleashing Prosperity Through Deregulation, and the White House Council on Environmental Quality (CEQ) February 25 interim final rule removing CEQ regulations...more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

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On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

Cozen O'Connor

Democratic AGs Secure Order Blocking Cuts to NIH-Funded Research Grants

Cozen O'Connor on

A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more

Smart & Biggar

New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations

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As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more

BCLP

PFAS Update: State Regulation of PFAS in Firefighting Foam and Equipment, November 2022

BCLP on

Numerous states have either enacted or proposed regulations regarding per- or polyfluoroalkyl substances (“PFAS”) present in Class B Aqueous Film-Forming Foams (“AFFF”) used for firefighting, or present in firefighters’...more

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