Drugs

Safety Outcomes Committee MAPP Out

CDER has issued a Manual of Policies and Procedures describing the organization, membership, responsibilities, and procedures of the Safety Outcomes Trials (SOT) Subcommittee of the Medical Policy Council. The document says that SOTs are typically large trials designed to assess whether a treatment increases the rate of certain clinical adverse events known to occur commonly in a treatment population, such as heart attacks and strokes, and would therefore not be readily interpretable as drug-related in the absence of a control group.

The subcommittee will serve as an advisory body in SOTs being considered in the Center. “In general,” the MAPP says, “all safety outcomes trials under active consideration by review divisions should be evaluated by the subcommittee. The subcommittee would not review SOTs that are part of established guidance, such as those for diabetes drugs, unless changes in practice are being considered.” The subcommittee is to:

provide advice to Office of New Drug review divisions when SOTs are being considered as pre- or post-approval requirements, with a goal to help assure that SOTs are well-designed, feasible, and needed, to encourage a consistent and sound policy across the Center;
catalog and analyze the ongoing experience with SOTs to inform future decision-making, and;
assist in developing guidance that articulates principles and best practices for developing and conducting SOTs.

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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