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Attorneys See Questions in LDT Policy Change

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Three Hyman, Phelps attorneys say an HHS announcement withdrawing a Trump administration policy on FDA review of laboratory-develo...

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Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decis...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Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-...

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FDA posts a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological ...

Hyperfine MRI Image Reconstruction Cleared

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FDA clears a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonan...

Imaging Drug OKd for Ovarian Cancer Detection

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FDA approves an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian ...