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Cell Therapeutics Appealing FDA Pixantrone Letter

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Cell Therapeutics says it will use FDAs formal dispute resolution process to appeal an agency recommendation that it conduct anoth...

FDA Creates Frances O. Kelsey Award

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FDA creates the Frances O. Kelsey Award for Excellence and Courage in Protecting the Public Health that will be awarded to FDA emp...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Bay Regional Medical Center, Bristol-Myers Squibb,Circulatory Technologies, Cort...

FDA Considering Bisphosphonate Label Changes

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FDA says it is considering bisphosphonate label changes to alert practitioners and patients to a risk of rare atypical femur fract...

Alkermes Vivitrol Seems OK for Opioid Dependence: Reviewers

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FDA medical reviewers say Alkermes Vivitrol appears effective in recently detoxified opioid-dependent patients but may have some i...

Tennis Champion in Sepracor Asthma Program

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Tennis champion Mary Joe Fernandez is a Sepracor paid spokesperson as part of an asthma education campaign.

Doctors Industry Payments Not Always Reported in Journals

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Researchers from the Institute on Medicine as a Profession say too few medical journals check the completeness and accuracy of ind...

ViroPharma Sues Over Bioequivalence Changes

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ViroPharma says FDA ignored federal law and its own regulations in determining that it is permitted to waive bioequivalence requir...

Draft Guide on Hepatitis C Drug Development

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Federal Register notice: FDA releases draft guidance Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agen...

International Nutrition Withdraws 4 NADAs

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Federal Register final rule: International Nutrition requests that FDA withdraw approval of four NADAs because they are no longer ...