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GPhA Hits Lack of GDUFA Progress

[ Price : $8.95]

The Generic Pharmaceutical Association tells FDA its members want to see improvements in access, transparency, and safety as a pre...

Whistleblower Group Solicits Physicians to Come Forward

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The Corporate Whistleblower Center urges physicians to come forward with proof of a medical device or pharmaceutical company that ...

FDA Extends Date on GDUFA Meetings

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Federal Register Notice: FDA extends the date for public stakeholders to notify FDA of their intent to participate in consultation...

Committee to Discuss Pediatric Safety Reviews

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 9/16 to discuss pediatric-focused safety reviews for 17 produ...

Infectious Disease Designation for Basilea Antibiotic

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FDA grants Basilea Pharmaceutica a Qualified Infectious Disease Product designation for its investigational drug ceftobiprole and ...

Study Finds No Difference Between CoreValve and Sapien Devices

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Researchers find that outcomes data are similar between Medtronics CoreValve and Edwards Sapien XT transcatheter heart valves.

Device Life Cycle Evidence Varies

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Yale University researchers say that medical device companies have fulfilled only 13% of postmarket studies within three to five y...

FDA Makes POCA Software Available

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FDA says its Phonetic and Orthographic Computer Analysis software used for finding similarities between two drug names is availabl...

Clear Visual Design for Trial Safety Data

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Members of the FDA Safety Graphics Working Group public guidelines to help scientists present complex clinical trial safety data i...

Improve Postmarket Review in MDUFA 4: Pew

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The Pew Charitable Trusts recommends that FDA use the MDUFA 4 negotiations to make several improvements to medical device postmark...