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FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and ...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FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.
FDA approves an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM syndrome (warts, hypogam...
Federal Register notice: FDA creates a public docket entitled Promoting Effective Drug Development: Identifying Opportunities and Priorities for the F...
