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FDA Approves Flexion NDA for Knee Pain

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Gottlieb Says FDA Working Daily on Puerto Rico Manufacturing Capacity

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FDA continues working with Puerto Rico-based manufacturing facilities to restore their capacity in order to prevent possible medic...

2017 CBER Recalls Up From 2016

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A FY 2017 CBER recall posting report details an 11% increase in total recalls over FY 2016.

ACLU Suit Challenges Mifeprex REMS

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The ACLU files suit against FDA REMS restrictions on access to the Mifeprex abortion pill.