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Food and Drug Administration (FDA) › Federal Pilot Programs › Clinical Trials

Goodwin

Move Fast: FDA is Accepting Submissions for the Pilot Program Class for FDA Commissioner’s National Priority Voucher Program

Goodwin on

FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...more

Hogan Lovells

FDA pilots oncology companion diagnostic test/device program as LDT rulemaking nears

Hogan Lovells on

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more

Knobbe Martens

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

Knobbe Martens on

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

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