The implosion of Avandia has raised several critical issues for diabetes drug developers, including whether companies can still rely on glycemic control as the primary endpoint for approval and the extent to which late-stage comparative trials conducted versus Avandia are still useful. The decisions FDA makes in the wake of Avandia will also be important milestones affecting other therapeutic categories, as they will reflect how the agency is assessing and monitoring drug safety generally.
Mark L. Ratner
The heated discussion around the use of GlaxoSmithKline PLC ’s rosiglitazone ( Avandia) has done more than raise issues of...
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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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
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.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
