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MR Testing, Labeling Guidance

[ Price : $8.95]

FDA issues a draft guidance on testing and labeling medical devices for safety in the magnetic resonance environment.

Bacterial Vaginosis Drug Development Guidance

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FDA issues a final guidance on developing drugs to treat bacterial vaginosis.

Draft Guide on Drug Study General Considerations

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Federal Register notice: FDA makes available a draft guidance entitled E8(R1) General Considerations for Clinical Studies.

FDA, Dassault Systmes Extend Collaboration

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FDA extends for five years its medical device innovation collaboration with Frances Dassault Systmes.

FDA Expanded OK for Leo Pharmas Psoriasis Therapies

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FDA expands the approval for Leo Pharmas Enstilar and Taclonex to treat plaque psoriasis in patients 12 years and older.

Ultragenyx Triheptanoin NDA for Genetic Disorder

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Ultragenyx Pharmaceutical files an NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders.

ParaGard Ad Draws Untitled Letter

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CDERs Office of Prescription Drug Promotion says a CooperSurgical TV spot for ParaGard is misleading because it doesnt give risk i...

Mercks Keytruda Approved for Esophagus Tumors

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FDA approves Mercks Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma ...

Final Guide on Oncology Radiopharm. Drug Studies

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FDA publishes a final guidance with information on the design of an appropriate nonclinical program for developing oncology therap...

Drug User Fee Rates Set by FDA

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Federal Register notice: FDA establishes the prescription drug user fee rates for fiscal year 2020.