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Regulatory Requirements Drug Pricing Public Health

Hogan Lovells

Medicines shortages under the EU pharma law package

Hogan Lovells on

The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Foley & Lardner LLP

FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews

Foley & Lardner LLP on

Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more

Smart & Biggar

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

Smart & Biggar on

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

Wilson Sonsini Goodrich & Rosati

FDA Announces “Priorities for a New FDA” and a New Vouchers Program to Address National Priorities

On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...more

Husch Blackwell LLP

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know

Husch Blackwell LLP on

On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more

Venable LLP

Life in the Fast Lane! FDA Announces the Commissioner's National Priority Voucher Program

Venable LLP on

On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more

Arnall Golden Gregory LLP

Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 33 - March 2025

The Georgia House of Representatives achieved the trifecta on Thursday, combining three favorite legislative traditions in one moment on the floor: recognition of a local novelty with an invite resolution, the appearance of a...more

Goldberg Segalla

FDA Approved Journavx, a Non-Opioid Drug for Pain Management

Goldberg Segalla on

On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...more

Smart & Biggar

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

Smart & Biggar on

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

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

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