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.
Federal Register notice: FDA makes available a guidance entitled Allergic Rhinitis: Developing Drug Products for Treatment.
CDER issues a MAPP clarifying the refuse-to-file process for specific types of drug applications.
Intuitive Surgical files a 510(k) for the companys new flexible robotic-assisted, catheter-based platform for lung airway biopsies.
FDA deputy commissioner Anna Abram says the agency is making significant progress on action plans to improve drug competition and access to biosimilar...
Federal Register notice: FDA extends the comment period on six draft guidance documents about developing human gene therapy products.
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical D...