Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Materials and Component...
Federal Register notice: FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Correspondin...
FDA plans a 6/13 listening session as part of its plan to revamp the use of advisory committees.
FDA offers a four-year enforcement discretion phase-out under a just-released final rule regulating laboratory-developed tests.
FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and ...
SonarMed recalls its SonarMed Airway acoustic ventilator sensors due to a restricted inner diameter of the device resulting in difficulty passing a su...
Federal Register notice: FDA schedules a 5/24 Advisory Committee meeting to discuss Novo Nordisks BLA for insulin icodec.
FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.
