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Ferumoxytol Resubmission Response Complete

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FDA says Amag Pharmaceuticals resubmission of its ferumoxytol NDA is a complete response.

Further CorCap Study Questioned

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Public Citizen says FDA approval of Acorn Cardiovasculars CorCap without further advisory committee review would abdicate its resp...

FDA OKs Twice-weekly Premarin for Dyspareunia

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FDA approves an NDA supplement for a new indication for Premarin vaginal cream 0.5 g a twice-weekly dosing regimen to treat moder...

FDA Reports Resolved Shortage with Vinblastine

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FDA says APP Pharmaceuticals is reporting that its vinblastine sulfate injection is no longer in short supply.

Comment Sought on Formal Sponsor Meetings

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Federal Register Notice: FDA seeks comments on a guidance on formal meetings with sponsors and applicants for PDUFA products.

Participants Sought to Select CBER Panel Members

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Federal Register Notice: FDA requests industry participants in the selection of nonvoting industry representatives on CBERs adviso...

FDA Offices in China to Open

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FDA commissioner Andrew von Eschenbach opens FDAs three permanent offices in China next week.

Quality, Reporting Problems at Power Interventions

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FDAs Philadelphia District Office warns Power Medical Interventions over quality and medical device reporting violations at its ma...

FDA OKs Focalin 30-min Onset of Action Claim

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FDA approves a 30-minute onset of action labeling claim for Novartis ADHD drug Focalin XR extended-release capsules.

Obama Team Starting Agency Review

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Obama transition team members are heading into federal agencies amid anonymous comments suggesting a major shake-up to rid FDA of ...