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Conflicts of Interest Seen in Meta-Analyses

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An NPR reports looks at researchers concerns about conflicts of interest in meta analyses.

FDA Fast Track for Chromocell/Astellas Drug Candidate

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FDA grants Chromocell and Astellas Pharma a fast track designation for drug candidate CC8464/ASP1807 for managing neuropathic pain...

Cut Fentanyl Off-Label Use: Senator Markey to FDA

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Sen. Ed Markey asks FDA to step up efforts to curb off-label prescribing of Insys Therapeutics fentanyl product Subsys.

FDA Reports Progress in Clinical Trial Diversity

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FDA acting associate commissioner Janice Soreth says progress has been made on almost all of 27 action items intended to improve d...

FDA Looks to Enhance Data Integrity Detection Tools

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In response to increasing data integrity citations in Warning Letters and inspections, FDA signs an agreement with CluePoints to d...

CDRH Begins Standardizing Medical Device Evaluation

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An extramural CDRH Case for Quality working group reports on initial steps to develop a standardized way for hospitals to compare ...

Rule Amends Definition of Custom Devices

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Federal Register Final Rule: FDA amends its regulations on the definition of a custom device to include new enumerated statutory r...

FDA Orphan Status for ALS Drug

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FDA grants MediciNova an orphan drug designation for MN-166 (ibudilast) for treating amyotrophic lateral sclerosis.

BioFire Gains Clearance for Respiratory Test

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FDA clears a BioFire Diagnostics 510(k) for the FilmArrayRespiratory Panel EZ, intended for use in detecting 11 viral and three ba...

AstraZeneca Stops Phase 2 Trial of Asthma Drug

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AstraZeneca says it has stopped a Phase 2a trial for asthma therapy AZD9412 (inhaled interferon beta) based on an interim analysis...