FDA sets a 10/19 public meeting on standardized data for electronic submission of Pharmaceutical Quality/Chemistry Manufacturing and Control data.
FDA airs concerns about misconnections with enteral devices.
FDA clears an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the Iridex reti...
FDA approves Tevas Cassipa, a stronger dose of buprenorphine and naloxone sublingual film for maintenance treatment of opioid dependence.
FDA issues a draft guidance saying it will exercise enforcement discretion to allow companies that produce probiotic dietary supplements to declare th...
FDA says the Avella Specialty Pharmacy acquisition Advanced Pharma produced compounded drugs that violated the Federal Food, Drug, and Cosmetic Act.
An Ohio State University medical school professor asks FDA to expand 510(k) exemption status to include optical sensor devices used for relaxation of ...
Federal Register notice: FDA makes available a guidance entitled Nonallergic Rhinitis: Developing Drug Products for Treatment.