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FDA Denies Sun Petition on Doxil Reference-listed Drug Designation

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FDA denies a citizen petition filed by Greenblum & Bernstein asking the agency to withdraw its designation of Suns generic form of...

FDA Approves a Silvergate Pharma sNDA for Epaned

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FDA approves a Silvergate Pharmaceuticals supplemental NDA for Epaned (enalapril maleate powder for oral solution) for treating sy...

FDA Accepts Astellas NDA for Anti-fungal Therapy

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FDA accepts for review an Astellas NDA for isavuconazole for treating invasive aspergillosis and invasive mucormycosis (also known...

FDA Posts July Animal Drug Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect July approval actions.

FDA Corrects Notice on Drug/Biologic Safety Reports

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Federal Register Final rule: FDA corrects an omission in an 8/10 Federal Register notice on postmarketing safety reports for drugs...

FDA Approves Sanofis Menactra Vaccine Booster

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FDA approves Sanofi Pasteurs Menactra conjugate vaccine for booster vaccination against meningococcal disease.

Court Reverses and Sides with FDA on Generic Precedex

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The Maryland federal district court reverses course and grants FDA summary judgment in a lawsuit brought by Hospira that challenge...

Oral Arguments Set in Biosimilars Declaratory Judgment Appeal

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The Federal Circuit Court of Appeals hears oral arguments 9/10 on a California federal court dismissal of a Biosimilars Price Comp...

FDA Device Inspections Up 25% Over Past Five Years

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Medical device inspections jump 25% since 2009, according to an analysis by Greenberg & Traurig attorneys.

FDA Corrects Notice on E-Safety Reports

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Federal Register Final rule: FDA corrects an incorrect number in a 6/10 Federal Register notice on electronic postmarketing safety...