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FDA says it is working in several ways with manufacturers to try to mitigate the current shortage of immune globulin products.[ Price : $8.95]
FDA says Pfizer has recalled two lots of its migraine drug Relpax because they may not meet the company microbiological specificat...[ Price : $8.95]
FDA grants V-Wave a breakthrough device designation for its interatrial shunt for heart failure.[ Price : $8.95]
FDA describes updates it will make to the inactive ingredient database as required under GDUFA 2.[ Price : $8.95]
A New York Times editorial suggests three steps to address problems arising in expedited drug approvals, including extremely high ...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Steri...[ Price : $8.95]
FDA and Syapse announce a multi-year research effort to look at use of real-world evidence in oncology regulatory decisions.[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance on gastroparesis drug development.