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Medistem Files Clinical Hold Response on Stem Cell Therapy

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Medistem files a response to a 2009 FDA clinical hold on the company's Phase 1 clinical trial entitled Allogeneic-Unrelated, Menst...

FDA Clears New ELISA Kit for Diagnosing Arthritis

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FDA clears an Axis-Shield 510(k) for a new version of its anti-CCP ELISA kit for diagnosing rheumatoid arthritis.

FDA Says Roxanne Shortage with Levorphanol Resolved

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FDA says a drug shortage involving Roxanne Laboratories levorphanol 2mg tablets has been resolved.

QrxPharma Completes NDA Submission on Pain Drug

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QRxPharma says it has submitted an NDA clinical data package for MoxDuo IR (morphine and oxycodone) as part of its rolling NDA sub...

FDA 'Orphan Status' for Buerger's Cell Therapy

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FDA grants orphan status to Pluristem Therapeutics for its PLX cells for treating thromboangiitis obliterans (Buerger's disease).

Recall Vaginal Mesh Products: Public Citizen

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Public Citizen says FDA should order firms to recall all surgical mesh products using non-absorbable material that are used in tra...

FDA Revises Food Safety Warnings in Animal Drug Regs

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Federal Register Final rule: FDA amends the animal drug regulations to revise human food safety warnings on dosage form new animal...

More Than 50% HHS Employee Waivers Not Documented

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The HHS inspector general says the department should do a better job of documenting employee conflict of interest waivers and ensu...

Fred Fricke, FDA Forensic Lab Founder, to Retire

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FDA Forensic Chemistry Center founder and director Fred Fricke will retire from the agency this week after 49 years service.

IoM Shoots Down MMR Vaccine/Autism Connection

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An Institute of Medicine Committee said available scientific evidence favors rejecting a causal connection between MMR vaccine and...