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CDER/CBER Review Change Supplement Deficiencies

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Representatives from CDER and CBER discuss deficiencies in submissions for post-approval changes that fail to reach first-cycle ap...

Significant Increase in Online Health Info

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ComScore Pharmaceutical Marketing Solutions says the online health information category grew 21% in the past year.

FDA Clears Dynaplasty Devices

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FDA clears MiCardias Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR.

Proteon Drug Candidate on Fast Track

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FDA gives fast track designation to Proteon Therapeutics investigational drug PRT-201 for improving vascular access in dialysis pa...

Priority Review for Kidney Cancer Drug

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FDA gives priority review to Novartis investigational advanced kidney cancer drug Afinitor.

FDA Approves Serdaxin Trial

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FDA approves a Phase 2 trial of Rexahns Serdaxin for treating major depressive disorder.

Advisors Support Pfizers Fablyn

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FDAs Reproductive Health Drugs Advisory Committee votes 9-3-1 to recommend approval of Pfizers Fablyn for treating osteoporosis on...

Promotional Pitfalls of New Product Launches

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An expert panel at FDLIs Annual Advertising & Promotion Conference offers advice to advertisers concerning pitfalls to avoid when ...

Med Center Conflict Policies Compared

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The Institute on Medicine as a Profession says some of the nations academic medical centers have adopted strong conflict of intere...

CEOs at Risk in Drug Ad Suits, Panelists Say

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Federal prosecutors warn that company CEOs have personal responsibility in Federal False Claims Act litigation over off-label use ...