Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance
Details
The document's own metadata, straight from regulations.gov.
- Posted
- Dec 22, 2023
- Comment period
- Dec 22, 2023 – Mar 22, 2024
- Agency
- Food and Drug Administration (FDA)
Overview
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- Mar 21, 2024Comment from Daiichi SankyoSupportBusiness📎 Attachment
Daiichi Sankyo, a global pharmaceutical company, submitted comments providing specific technical feedback and requests for clarification on the draft guidance for master protocols. They advocate for more detailed guidance on oncology trials, randomization practicalities, and the inclusion of combination regimens.
Read comment → - Mar 21, 2024Comment from AstrazenecaSupportBusiness📎 Attachment
AstraZeneca supports the draft guidance on Master Protocols for Drug and Biological Product Development, noting it is timely and supportive of innovation. The company suggests expanding the guidance to include more detail on basket trials, precision medicine, rare diseases, and practical considerations like patient centricity and sample size estimation.
Read comment → - Dec 25, 2023Comment from Cong ChenOtherIndividual
The commenter provides technical feedback regarding the statistical allocation ratios for umbrella trials in drug development. They argue that the current recommendations may not be optimal for trials where experimental arms enter at different times or have overlapping populations, citing specific research for a more complex formula.
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