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Court Should Retreat from Wyeth Decision: Troy

[ Price : $8.95]

Former FDAer Daniel Troy calls on the Supreme Court to back away from its Wyeth v Levine decision and allow much more preemption o...

Expedited Pathway Granted to Wearable Artificial Kidney

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FDA grants an Expedited Access Pathway designation for the first Wearable Artificial Kidney which was invented by UCLA/Cedars Sina...

Sanofi, BioNTech Partner to Develop 5 Immunotherapies

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Sanofi and BioNTech enter into a multiyear collaboration and license agreement to discover and develop up to five cancer immunothe...

OMB OKs Info on Blood Cell Separator

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a special controls guidance o...

Health Canada, FDA Webinar on Pharmaceuticals

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Federal Register Notice: FDA will hold a regional public webinar 11/12 on Health Canada and U.S. FDA joint public consultations on...

FDAs Science Board to Meet

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Federal Register Notice: FDAs Science Board will meet 11/18 to hear topics such as precision medicine, and health informatics init...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Family Pharmacy and Sound Healing Arts, PC, dba Grounds for Tea.

FDA Sends Info on Rx Drug Labeling to OMB

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

FDA Grants Progesterone Gel Guidance Request

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FDA grants and denies portions of a Watson petition on bioequivalence guidance and studies for progesterone gel.

CGMP, Other Violations at American Family Pharmacy

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FDAs Detroit District Office warns American Family Pharmacy about CGMP and misbranding violations.