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Fennec Pharma Hit with 2nd Complete Response

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FDA sends Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for pr...

Nominations for Radiation Safety Standards Panel

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Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safe...

Real-World Data Guidance on Using Registries

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Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decis...

Comments on FDA Real-World Data Guidance

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Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-...

Teleflex Recalls Percutaneous Thrombolytic Device

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Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the in...

AstraZeneca, Merck sNDA for Lynparza

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FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of pa...

Mercks Covid Drug has 52% Risk Reduction: FDA

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An FDA advisory committee briefing document says Mercks oral antiviral molnupiravir is associated with a relative risk reduction ...

Regulatory Review Period for Zepzelca

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pharma Mars Zepzelca (lurbi...

Info Collection on Rx Drug User Fee Program

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Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.

Real-World Data Guidance on Using Registries

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FDA posts a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological ...