BIO Comments on FDA Draft Guidance on Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry.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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry.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