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FDA Proposes Rule for Some Drug Shortage Notifications

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FDA issues a strategic plan and proposes a new early notification rule to help address potential drug shortages

Comments Sought on Adolescent DTC Promotion Info

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Federal Register Notice: FDA seeks comments on a proposed collection of information on direct-to-consumer promotion directed at ad...

Info on Electronic Products Sent to OMB

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Federal Register Notice: FDAs submits a proposed collection of information on electronic products to the Office of Management and ...

Info on Device Presubmission Program Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Orphan Status for Stem Cell Therapeutics Leukemia Treatment

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FDA grants Stem Cell Therapeutics an orphan drug designation for the use of tigecycline in treating acute myeloid leukemia.

Actavis Sued Over ANDA for Generic Copy of Absorica

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Actavis files an ANDA seeking approval to market a generic copy of Ranbaxys Absorica (isotretinoin) capsules, and the company is s...

Feds Seeking Info on AstraZeneca PLATO Trial

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AstraZeneca says it has received a civil investigative demand from the U.S. Department of Justice seeking documents and informatio...

FDA Asks Ariad to Suspend Iclusig Marketing

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FDA says Ariad has agreed to its request to suspend sales and marketing of Iclusig due to safety concerns.

Policies Needed for Advisory Panel Interest Conflicts: Public Citizen

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Public Citizen Health Research Group founder Sidney Wolfe says FDA must immediately improve ethics training for advisory committee...

Results of Large Clinical Trials Often Unpublished

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Researchers writing online in the BMJ say too few large clinical trials are publishing results in peer-reviewed journals or postin...