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Docket Open on Sodium Nitroprusside Pediatric Studies

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Federal Register Notice: FDA will open a public docket to make available a report on the pediatric studies of sodium nitroprusside...

CDER Hosts Clinical Investigator Training

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CDER and Duke University Office of Continuing Medical Education co-sponsor a three-day training course for clinical investigators ...

Ethicon Recalls Numerous Thrombin Lots

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Ethicon recalls numerous lots of thrombin due to a manufacturing process deviation that may have led to decreased potency in some ...

Dietary Supplement Claims Dont Meet FDA Requirements

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The HHS Inspector General says FDA should seek legal authority to review manufacturer substantiation for dietary supplement struct...

Alere Agrees to FDA-requested Tighter Release Specs

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Alere Inc. says it has agreed to FDA-requested tighter release specifications for the companys Triage meter-based products.

Mallinckrodt Wants Exalgo ANDA Limits

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Mallinckrodt asks FDA to require specific bioequivalence measures for any generic form of its Exalgo.

6-year Generic Wellbutrin Puzzle Solved; Teva Product Pulled

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An FDA-commissioned bioequivalence study of Tevas Budeprion XL 300mg ends six years of controversy over adverse effects in patient...

Study Says Pediatric Exclusivity Pays Off

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A new study says that pediatric drug exclusivity strategies can see a return-on-investment on average of $130 for every $1 spent.

Medtronic Gets FL Case Dismissed on Preemption Grounds

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A Florida federal judge grants a Medtronic motion to dismiss on preemption grounds in a product liability suit involving the compa...

FDA Cancels Panel Meeting on Celgenes Pomalidomide

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FDA tells Celgene that it has canceled an 11/8 Oncologic Drugs Advisory Committee meeting that was intended to review the companys...