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Adverse Events Mount for Pradaxa, Group Says

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A drug adverse event watchdog group highlights a surge in post-marketing reports seen with Boehringer Ingelheim Pharmaceuticals's ...

Northwestern Survey Eyes Recommendations on 510(k) Revamp

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A recent Northwestern University survey serves as the basis for recommendations submitted to FDA for revamping its 510(k) clearanc...

Millennium Withdraws Velcade sNDA

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Millennium withdraws a supplemental NDA for Velcade (bortezomib) for injection and its use in combination with rituximab in patien...

Scios Pays $85 Million in Natrecor Guilty Plea

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Johnson & Johnson subsidiary Scios pleads guilty in California federal court to a misdemeanor charge related to an unapproved use ...

Study Looks at DTC Genetic Tests

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A new study by Mayo Clinic researchers examines whether direct-to-consumer genetic tests cause patients to experience excessive wo...

Congressman Seeks Answers from 5 Gray Drug Marketeers

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Representative Elijah Cummings (D-MD) sends letters to five gray market drug companies seeking information on how they obtain thei...

FDA Approves Cialis for Benign Prostatic Hyperplasia

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FDA approves Eli Lilly's erectile dysfunction drug Cialis (tadalafil) for treating the signs and symptoms of benign prostatic hype...

OIG to Probe REMS, Dispute Resolution, and IND Submissions

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HHS Office of Inspector General plans to pursue a number of FDA-related investigations in FY 2012, including a review of the agenc...

FDA Repudiates Dan Troys Preemption Preamble

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FDA says its position on federal preemption of state failure-to-warn suits, crafted by Bush Administration chief counsel Dan Troy,...

Sterility Test Change Clarification Sought

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BIO asks FDA to clarify a provision in its proposal to amend biological product sterility test requirements.