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Animal Drug User Fee Reauthorization Public Meeting

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Federal Register notice: FDA announces a 11/2 public meeting entitled Animal Drug User Fee Act.

Regulatory Review Period Determined for Impella 2.5 System

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europes Impella 2.5...

Regulatory Review Period Determined for Bayers Kovaltry

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Bayers Kovaltry (antihemoph...

FDA Approves Flexion NDA for Knee Pain

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FDA approves a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended...

Sens. Warren, Grassley Call for Device Identifiers on Claims Forms

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Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) call for medical device identifier information be added to Medicare cla...

FDA Approves Flexion NDA for Knee Pain

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FDA approves a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended...

Regulatory Review Period for Biogen Idecs Tecfidera

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Federal Register notice: FDA has determined the regulatory review period for patent restoration purposes for Biogen Idecs Tecfider...

Baxter Recalls Intralipid Lot Due to Subfreezing Storage

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Baxter International recalls one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100 mL, after it was exposed to sub...

Policy on Providing ANDA Review Status Updates to Sponsors

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CDER publishes a new Manual of Policies and Procedures (MAPP 5200.12) on Communicating Abbreviated New Drug Application Review Sta...

FDA Awards 15 Clinical Research Grants for Rare Diseases

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FDA awards 15 new clinical trial research grants totaling more than $22 million to advance product development for patients with r...