“Clear specific guidance” from the agency would help close the perception gap between what types of data industry thinks FDA wants and what the agency actually expects, according to a summary of a 2012 Institute of Medicine workshop.
FDA guidance on use of large simple trials would help encourage conduct of such studies in lieu of longer, more complex and costly randomized controlled trials, according to a recently released Institute of Medicine report.
Such guidance could help reduce the fear – which FDA asserts to be unfounded – among biopharmaceutical sponsors that the...
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The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.
The 340B program increases federal health care costs by encouraging the use of costlier medications, the Congressional Budget Office said. But the agency also did not provide a specific estimate of the impact.
Stealth has until March 2026 to begin enrolling its confirmatory trial for its Barth syndrome drug elamipretide, marking a rare instance where a novel drug received accelerated approval even though the required postmarketing study was not underway.
The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.
Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.
The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.
CMS proposals would reduce Medicare payments for cell and gene therapy manufacturing and preparation, which will further disincentivize outpatient or community-based treatment, advocates and sponsors said.
