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Guidance on Homologous Use of Human Cells et

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Federal Register Notice: FDA releases a draft guidance: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Prod...

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 ...

FDA Issues Revised Liposome Guidance

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FDA issues a revised guidance on information needed with an application for liposome drug products reviewed by CDER.

FDA Extends Dispenser Tracing Info Deadline

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FDA revises a product tracing compliance guidance to give more time before it takes enforcement action against drug dispensers who...

Stakeholders Appreciate Registry Report

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Stakeholders say they generally support a Medical Device Registries Task Force report on a national medical device evaluation syst...

Researchers Working on Heart-powered Pacemaker

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University of Buffalo engineering researchers say they are building a prototype of a pacemaker that would operate without batterie...

Docket Established for Input on Technologies in Clinical Trials

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Federal Register Notice: FDA establishes a public docket to solicit input on the use of technologies and innovation in conducting ...

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...