Drugs

Drug Development Master Protocol Guidance

FDA has published a draft guidance, Master Protocols for Drug and Biological Product Development, with recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submitting documentation to support regulatory review. The document says its primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of the effectiveness of a drug.

“The concepts discussed may also be useful to consider for early-phase or exploratory umbrella and platform trials as well as those conducted to satisfy post-marketing commitments or requirements,” FDA says. “The recommendations and considerations in this guidance do not apply to master protocols evaluating first-in-human drugs given the unique attributes from both a trial design and regulatory perspective that must be considered.”

The guidance includes an Introduction; Background; Considerations on Design and Analysis; Considerations on Trial Oversight, Data Sharing, and Dissemination of Information; References; and an Appendix.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome