Tytek Medical recalls its PneumoDart-Pneumothorax Needle due to the risk of blocked needles caused by an adhesive left over from assembly.
FDA issues two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments waivers for certain products.
FDA approves Eli Lillys Trulicity (dulaglutide) for reducing major adverse cardiovascular events in adults with Type 2 diabetes who have established c...
FDA identifies about 150 prescription drugs (antibiotics, generics and some brand drugs) that could be in short supply if plants in China that make th...
Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format Certain Human Pharmaceut...
Federal Register notice: FDA seeks comments on a draft Electronic Common Technical Document v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Mod...
Federal Register notice: FDA announces a 5/15 Allergenic Products Advisory Committee meeting to review DBV Technologies Peanut (Arachis hypogaea) Alle...
Two senior CDER officials discuss how real world data and real world evidence can be used in making regulatory decisions, and describe challenges to e...