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CBER Submissions System Hacked and IDs Stolen

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CBER says its online submission system was compromised 10/15 and user information was obtained by the unidentified hacker.

FDA Releases Survey on da Vinci System Experiences

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FDA releases results of its survey of 11 surgeons on their experiences using the da Vinci Surgical System.

Discovery Labs to Start Aerosurf Phase 2 Trial

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FDA approves a Discovery Laboratories IND for Aerosurf, allowing the company to launch a Phase 2 clinical trial program.

FDA Releases Burzynski Research Institute FDA-483

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FDA releases an FDA-483 from an inspection at Burzynski Research Institute.

FDA Gives Medicines Co. QIDP Designation for Antibiotic

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FDA gives the Medicines Co. a Qualified Infectious Disease Product designation for oritavancin and its use in treating acute bacte...

FDA Says Sarepta NDA for Eteplirsen is Premature

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FDA tells Sarepta Therapeutics that its planned NDA filing is premature for eteplirsen and its use in treating Duchenne muscular d...

Pfizer Rapamune Study Misses Primary End Point

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A Phase 3B/4 study involving Pfizers Rapamune in kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) t...

Fast Track Status for Alnylam Pharmas Patisiran

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FDA grants Alnylam Pharmaceuticals a fast track designation for ALN-TTR02 (patisiran) for treating transthyretin-familial amyloid ...

FTC Workshop to Examine Biosimilar Naming Issues

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The Federal Trade Commission hosts a workshop to examine competition issues surrounding biologic and follow-on biologic medication...

FDA Cites Daiichi Sankyo Over Mailer to Physicians

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A just-post FDA untitled letter cites Daiichi Sankyo for making misleading claims in a mailer to health professionals for hyperten...