A common theme in FDA’s review of three different weight loss drugs has been discussion of whether a Risk Evaluation & Mitigation Strategy program can help assure appropriate use of the therapies. FDA clearly thinks the answer is “no.” But that doesn’t end the discussion of what tools can be used to help curb off-label use.
When it comes to finding a path to approval for obesity therapies in the U.S., the Food & Drug Administration has concluded that a Risk Evaluation & Mitigation Strategy is not the answer after all. FDA made that very clear this summer in two very different contexts that involved direct discussion of whether to use the REMS authority in the weight loss class.
The first and most direct decision came when the Food & Drug Administration approved Arena Pharmaceuticals Inc./Eisai Co....
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
