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Cellular Therapy Guidance

[ Price : $8.95]

FDA issues a guidance on trial information for sponsors of cellular therapy for cardiac disease.

FDA Wont Stay Approval of Pending Fentanyl Patch Applications

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FDA approves some elements of a Mylan petition on use of overlays with fentanyl patches.

Court Orders Pfizer to Pay $95.2 Million in Neurontin Restitution

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A Massachusetts federal judge orders Pfizer to pay nearly $96 million in restitution to Kaiser Health Plan for excess payments the...

OMB OKs Info on Sentinel Initiative

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Federal Register Notice: OMB approves an FDA collection of information on evaluating potential data sources for the Sentinel Initi...

Comments Sought on Pharmacogenomic Data

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Federal Register Notice: FDA seeks comments on the information collection resulting from recommendations to IND, NDA, or BLA spons...

Comments Sought on Importer Entry Notice Info

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Federal Register Notice: FDA seeks comments on a revision of an approved OMB collection of information on FDAs Importer Entry Noti...

CDER Compliance Expert Joins Parexel

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CDER Division of Manufacturing and Product Quality International Compliance Branch chief Edwin Rivera-Martinez retires from the ag...

Actavis Asks Consumers to Return Recalled Fentanyl Patches

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Actavis asks consumers who have recalled Fentanyl Transdermal System patches to return them to the company.

FDA Asked to OK Sedasys System Appeal

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Ethicon Endo-Surgery asks FDAs Office of the Commissioner to grants its appeal of a CDRH decision denying a PMA for its Sedasys Sy...

CBO Analyzes Impact of New Medicare, Medicaid Discounts

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The Congressional Budget Office looks at the impact on drug prices of new rebates and discounts for drugs purchased for Medicare a...