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Drug Pricing › New Guidance › Food and Drug Administration (FDA)

Hogan Lovells

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Morgan Lewis - As Prescribed on

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Morgan Lewis on

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

McGuireWoods LLP

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

McGuireWoods LLP on

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

Akin Gump Strauss Hauer & Feld LLP on

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and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

Foley Hoag LLP

Medicare Drug Price Negotiation Program Initial Guidance

Foley Hoag LLP on

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

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