BIO Comments on FDA Draft Guidance on Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry.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.
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory based non-profit trade associations, each of…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry.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.