Federal Register notice: FDA issues a priority review voucher to Pharming Technologies that was related to its rare pediatric disease drug Joenja (len...
FDA provides further clarification about a safety alert issued earlier this month that recommended against the use of certain surgical N95 respirators...
Federal Register notice: FDA makes available a draft guidance entitled Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.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...
