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FDA Approval Proposed Legislation Pharmaceutical Industry

Venable LLP

BiologicsHQ Monthly Injection - March 2025

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On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Goodwin

New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs

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On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more

Venable LLP

Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar...

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On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 12

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In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more

Hogan Lovells

A new right for American patients: The Right to Try

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On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more

Farrell Fritz, P.C.

Cannabis Industry Update – April 2018

Farrell Fritz, P.C. on

With so much happening in the cannabis industry we thought we’d take this time to highlight some of the industry’s most recent happenings. ...more

Hogan Lovells

Outlook for OTC drug regulation

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Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000 products marketed. ...more

Holland & Knight LLP

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

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On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Benesch

Senators Introduce the CREATES Act

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In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

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