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Globalization Impacts FDAs Operating Centers

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Representatives of FDA operating Centers provide attendees at the 2008 PDA/FDA Joint Regulatory Conference (9/10) with updates on ...

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.

FDA Issues Draft Animal Rule Concept Paper

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FDA issues a draft concept paper on using an animal model to establish a drug or biologic products efficacy under the Animal Rule....

Quality Problems at Sgarlato Plant

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FDAs San Francisco District Office says Quality System problems were found in an inspection at Sgarlato Laboratories manufacturing...

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 ...