Federal Register notice: FDA makes available a draft guidance entitled Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.
FDA releases the form FDA-483 with 10 observations from a recent inspection at a Lupin drug manufacturing facility in Pithampur, India.
Sarepta raises several points for FDA consideration on an agency draft product-specific guidance for golodirsen.
FDA clears a GE HealthCare 510(k) for its Carescape Canvas patient monitoring platform for precise, flexible patient care.
An FDA online post describes research creating new quantitative structure-activity relationship models to predict blood-brain barrier permeability.
Johns Hopkins students who belong to Universities Allied for Essential Medicines say FDAs failure to fine companies that dont submit clinical trial da...
FDA commissioner Robert Califf tells a Senate appropriations hearing that FDA and CMS are working to make sure clinical trials for products seeking ac...
DBV Technologies receives written responses from FDA after a pre-BLA meeting in February about the regulatory path for investigational Viaskin Peanut ...
