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FDA sends Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for pr...[ Price : $8.95]
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safe...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decis...[ Price : $8.95]
Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-...[ Price : $8.95]
Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the in...[ Price : $8.95]
FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of pa...[ Price : $8.95]
An FDA advisory committee briefing document says Mercks oral antiviral molnupiravir is associated with a relative risk reduction ...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pharma Mars Zepzelca (lurbi...