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Public Workshop on Clinical Trial Safety

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 12/2: Clinical Trials Assessing Safety and Efficacy in Diverse Populations....

Comments Re-opened on Human Cells Guidance

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Federal Register Notice: FDA reopens the comment period for the draft guidance on minimal manipulation of human cells, tissues, an...

Hearing on Human Cells Guidances

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Federal Register Notice: FDA will hold a public hearing 4/13/16 on four recent draft guidance on the regulation of human cells, ti...

Comments Re-opened on Surgical Procedure

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Federal Register Notice: FDA reopens the comment period on a draft guidance: Same Surgical Procedure Exception: Questions and Answ...

OMB OKs Info on Generic Drug Correspondence

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

Integrity Applications Meets With CDRH on Glucose Tracker

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Integrity Applications says it recently met with CDRH officials to discuss its clinical trial protocol for GlucoTrack Model DF-F, ...

Sanofi Recalls Auvi-Q Due to Dosage Concerns

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Sanofi recalls all Auvi-Q (epinephrine injection, USP) due to the potential for inaccurate dosage delivery.

Warner Chilcott Guilty Plea in Drug Kickback Scheme

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Warner Chilcott agrees to plead guilty to a felony charge of health care fraud and pay $125 million to resolve its criminal and ci...

Info on Clinical Investigators 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 financial disc...

OMB OKs Info on Biosimilar Sponsor Meetings

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on meetings betwee...