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FDA Complete Response Letter for Verrica NDA

[ Price : $8.95]

FDA asks Verrica for additional CMC information on its VP-102 NDA intended to treat molluscum contagiosum.

TriNetX Signs Sentinel Agreement

[ Price : $8.95]

FDA signs a contract with TriNetX to expand its use of the platforms real-world data in the Sentinel program.

FDA Issues 4 Animal Drug Development Guidances

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FDA issues four draft guidances to help facilitate the development of new animal drug products.

FDA Refuse to File on HIV Drug

[ Price : $8.95]

FDA issues CytoDyn a refusal to file letter on its BLA for leronlimab (PRO 140), a CCR5 antagonist used in combination therapy wit...

FDA Releases RC Outsourcing FDA-483

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FDA releases an FDA-483 with eight inspection observations from an inspection at RC Outsourcing.

Revamp Gets Breakthrough Status for Heart Device

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FDA grants Revamp Medical a breakthrough device designation for its Doraya percutaneous device for treating acute heart failure.

Guide on HIV & Hepatitis Patients in Cancer Trials

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Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Patients with H...

Senators Want to Study Foreign Drug Supply Investment

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Sens. Rubio and Warren introduce legislation to study the impact of foreign government investment in the U.S. drug supply chain.

Reg Review Determined for Cartiva Device

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cartiva, a device used for ...

Tecentriq Plus Avastin Misses in Ovarian Cancer Trial

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Genentechs Phase 3 IMagyn050 study finds that the addition of Tecentriq (atezolizumab) to Avastin (bevacizumab), paclitaxel and ca...