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FDA Warns Cambrex After Facility Inspection

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FDA warns Cambrex over lab data collection and maintenance at its Milan, Italy, API manufacturing facility.

Some DTC Study Elements Not Useful: PhRMA

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PhRMA asks FDA to redesign its proposed study to investigate consumer response to drug benefit information in print and TV ads.

FDA Corrects Reg on Herpes Simplex Virus

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Federal Register Proposed rule/Direct final rule: FDA corrects its regulation classifying herpes simplex virus by removing the ref...

FDA Corrects Rule on MDR Electronic Submissions

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Federal Register Correction: FDA corrects a small error in an 8/21 proposed rule on electronic submission requirements for medical...

Comments Sought on Asthma Pregnancy Registry

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Federal Register Notice: FDA seeks comments on the mental models study of recruitment and retention into an asthma pregnancy regis...

Panels to Discuss Oxycontin

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Federal Register Notice: FDAs Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees will m...

Sponsor Name Added to Advisory Panel Notice

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Federal Register Notice: FDA changes the Agenda portion of the 9/23 meeting of the Anesthetic and Life Support Drugs and the Drug ...

Panel to Discuss MS Drug

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 10/14 to discuss Acorda The...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Allergan, Core Products, BioCentric Laboratories, Geromatrix Nutraceutical, MEKT...

Undoing Bush: FDA Begins Swift Enforcement Actions

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FDA presenters at a GMP conference defend the dismantling of a Bush-imposed Chief Counsels Office review for all Warning Letters, ...