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BIO Comments on FDA Draft Guidance on Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics

November 28, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry.

BIO welcomes guidance with information on master protocols. The comments provide suggestions for how to improve the clarity and completeness of the guidance.

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BIO Comment Letter Master Protocol 11-28-18

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