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Increlex Materials Mislead Healthcare Professionals: DDMAC

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CDERs Division of Drug Marketing, Advertising, and Communications warns Tercica about misleading professional promotional material...

Deficiencies Cited at Claris India and Claris U.S.

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FDA warns Claris Lifesciences on multiple violations found at its Indian and U.S. facilities.

Former Glaxo Attorney Indicted

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A federal grand jury indicts former Glaxo attorney Lauren Stevens for lying to FDA about off-label promotion of a drug.

Postmarket Requirements Report Released

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Federal Register Notice: FDA makes available the status of postmarketing requirements for approved drug and biological products.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Bioenergy, Claris Lifesciences, CP Pharmaceuticals, and Ipsen Group-Tercica.

Second OIG Probe on CDRH Misconduct Finds Nothing

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HHS Office of Inspector General closes its second investigation into CDRH misconduct involving allegations of management pressure ...

Implantable Device Safety Surveillance Can Work

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New research published in the Journal of the American Medical Association supports development of automated surveillance systems t...

Santarus to File NDA for Ulcerative Colitis

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Santarus plans to file an NDA with FDA in the second half of 2011 due to positive results from a Phase 3 European trial of budeson...

FDA Accepts Glaxo Resubmission on Horizant

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FDA accepts for review a GlaxoSmithKline response to an earlier agency-issued complete response letter on an NDA for Horizant (gab...

Most Required Post-marketing Studies on Schedule: FDA

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FDA says the vast majority of required post-marketing studies are proceeding on schedule.