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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

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FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction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On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and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

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