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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...

PharmaTech Source of Burkholder Cepacia Outbreak: FDA

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FDA identifies lots of oral liquid ducosate sodium manufactured by PharmaTech as the source of a multistate Burkholder cepacia out...

Guidance on Prescription-use Glucose Monitors

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Federal Register Notice: FDA makes available a guidance entitled Blood Glucose Monitoring Test Systems for Prescription Point-of-C...