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Guidance Details Post-Approval Responsibilities for Generics

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FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting require...

Stakeholders Press FDA to Pause Voucher Program Amid Transparency Concerns

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Stakeholders at FDA's public hearing on the Commissioners National Priority Voucher program urge the agency to temporarily suspend...

House Passes $7.1 Billion FDA Spending Bill

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The House passes FDAs appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.

FDA Rejects Xspray Pharma's Nilopki Application

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FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib design...

FDA Breakthrough Device Designations Top 1,280

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FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the e...

FDA Approves Lupin's Interchangeable Lucentis Biosimilar

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FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucen...

Diamantas Tries to Win Back Rare Disease Advocates

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FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease...

Faulty Drug Supply Chain Hurts Seniors: Hearing

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The Senate Special Committee on Aging hears testimony on how an unsecure U.S. drug supply chain is harming older patients.

Radiopharmaceutical Companies Want FDA Consistency

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Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.

Supreme Court Sides With Generics in Skinny Label Dispute

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The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved...