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FDA Extends Use of Older MedWatch Form

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FDA extends the use of an older version of its MedWatch 3500A form to allow industry time to modify their computer systems.

FDA Generic Drug Submissions Increase

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CDER Office of Generic Drugs director Gary Buehler reports a slight increase in workload last year added to stress felt in his ove...

FDA OKs Stronger Reyataz Dosage Strength

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FDA approves a 300 mg capsule formulation of Bristol-Myers Squibbs Reyataz to be used in combination therapy along with ritonavir ...

Panel to Discuss Celebrex for Junior RA

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Federal Register Notice: FDAs Arthritis Advisory Committee will meet 11/29 to discuss Pfizers Celebrex for the proposed indication...

Lilly Planning Cialis Ad Push?

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Advertising Age reports Lilly may be planning an advertising push for Cialis.

Panel to Discuss Stent Thrombosis Coronary Drug-Eluting Stents

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/7-8 to discuss stent thrombosis in coronary drug-eluti...

Generic Drug Petitions Waste Time, Dont Work

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FDA generic drugs counsel David Read says citizens petitions which critics charge are often used by branded drug manufacturers to...

FDA Working on User Fees for Generic Drugs

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As resistance to user fees grows, FDA gets $100,000 to study the feasibility of extending user fees to the review of generic drugs...

Mallinckrodt Booths Misleading

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DDMAC wants corrective messages for misleading Mallinckrodt MD-Gastroview, Optimark booth panels.

Guidance on Blood, Plasma Deviation Reporting

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Federal Register Notice: FDA releases a guidance document on biological product deviation reporting for blood and plasma establish...