FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were f...
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity di...
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the companys Impella ...
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.
FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computational modeling and simul...
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...
