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FDA Suggests Androxal Phase 2B Study Before Phase 3

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FDA suggests that Repros Therapeutics conduct a Phase 2B Androxal trial before moving to Phase 3 studies.

FDA 'Fast Track' Status for Sanofi Vaccine

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FDA grants Sanofi Pasteur a fast track designation for its investigational clostridium difficile vaccine candidate.

FDA Probing CT Scan Radiation Reports

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FDA says it has developed recommendations that should reduces instances of excess doses of radiation to some patients undergoing C...

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...