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FDA plans a 6/13 listening session as part of its plan to revamp the use of advisory committees.[ Price : $8.95]
FDA offers a four-year enforcement discretion phase-out under a just-released final rule regulating laboratory-developed tests.[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell a...[ Price : $8.95]
SonarMed recalls its SonarMed Airway acoustic ventilator sensors due to a restricted inner diameter of the device resulting in dif...[ Price : $8.95]
Federal Register notice: FDA schedules a 5/24 Advisory Committee meeting to discuss Novo Nordisks BLA for insulin icodec.[ Price : $8.95]
FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.[ Price : $8.95]
FDA approves an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM synd...[ Price : $8.95]
Federal Register notice: FDA creates a public docket entitled Promoting Effective Drug Development: Identifying Opportunities and ...