Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.
Drug sponsors should submit a “Race and Ethnicity Diversity Plan” early in clinical development that can be revisited and revised throughout a drug’s regulatory life to enhance diversity in clinical trials, the US Food and Drug Administration advises.
The agency describes what sponsors should include in the plan in a draft guidance, “Diversity Plans to Improve Enrollment...
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.
