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Panels to Discuss I.V. Anti-Seizure Drugs

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs and the Drug Safety and Risk Management Advisory Committ...

FDA Clears Integra Line of Rongeurs

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FDA clears an Integra LifeSciences Holdings 510(k) for its new line of extended length and detachable Ruggles Kerrison rongeurs, i...

Janssen Rejects FDA Risperdal Bioequivalence Recommendations

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Janssen says FDAs proposed bio equivalence requirements for generic intra-musculal risperidone will not be adequate.

FDA Clears Solta Laser for Removing Actinic Keratosis Lesions

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FDA clears a Solta Medical 510(k) for the Fraxel Re:store Dual laser for treating actinic keratosis lesions.

Boston Scientific Defibrillators OK'd for Certain Heart Failure Patients

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FDA approves a Boston Scientific PMA supplement for three cardiac resynchronization therapy defibrillators (CRT-D) to be used in t...

FDA Panel Nixes Arena Weight-loss Drug

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 9 to 6 to not recommend approval of Arena Pharmaceutical's weight...

Stomach Bleeding Warning Added to 3 Cold Meds

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FDA approves labeling changes for 24 drugs, including stomach bleeding Warnings for three OTC cold products.

ISTA Moves to Phase 3 with ''Dry Eye'' Drug

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ISTA Pharmaceuticals starts a Phase 3 clinical trial involving Remura (bromfenac ophthalmic solution) for alleviating dry eye dise...

Westmed Class I Recall of Resuscitation Devices

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Westmed initiates a Class 1 recall involving 24,384 units of its BagEasy Manual Resuscitation Devices.

Premarin Patient Testimonials False or Misleading

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CDERs Division of Drug Marketing, Advertising, and Communications says Web page video testimonials for Wyeths Premarin overstate i...