FDA issues a draft guidance with recommendations for applicants to use in writing the Drug Abuse and Dependence section of labeling for human prescrip...
FDA issues a draft guidance with recommendations for developing content and format of an Instructions for Use document for certain prescription drugs ...
Federal Register notice: FDA makes available a final guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifes...
Fresenius Kabi USA recalls two lots of fluorouracil injection due to the potential for them to contain glass particulates.
Edwards LifeSciences recalls its IntraClude Intra-Aortic Occlusion Device due to balloon rupture risks during use.
Federal Register notice: FDA issues a final rule to amend its regulations on internal agency supervisory review of certain decisions related to device...
Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of a nonvoting industry representat...
Sens. Warren and Murray ask FDA to answer questions about the CDRH progressive approval of medical devices program, which they say was denied by forme...