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Metaxalone not Withdrawn Due to Safety/Effectiveness: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that metaxalone tablets, 640 mg were not withdrawn from sale for reasons of safety or effe...

Adherium Sensor Cleared for Asthma Inhaler Compliance

[ Price : $8.95]

FDA clears an Adherium 510(k) for its Hailie sensor and its use with Tevas ProAir HFA, and GlaxoSmithKlines Ventolin HFA and Flove...

FDA Rejects INSYS NDA for Pain Spray

[ Price : $8.95]

FDA issues INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-sev...

FDA Clears Cepheid Xpert Xpress Flu/RSV Test

[ Price : $8.95]

FDA clears a Cepheid 510(k) for the Xpert Xpress Flu/RSV test.

Draft Guide on Rare Diseases with Substrate Deposition

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Federal Register notice: FDA makes available a draft guidance entitled Slowly Progressive, Low-Prevalence Rare Diseases with Subst...

Guide on Certain Pediatric Orphan Designations

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Federal Register notice: FDA makes available a final guidance entitled Clarification of Orphan Designation of Drugs and Biologics ...

LifeSignals LP1100 Life Signal Patch Cleared for Use

[ Price : $8.95]

FDA clears a LifeSignals 510(k) for its wireless LP1100 Life Signal Patch that is intended for enabling the next generation of wea...

FY 2019 Generic Drug User Fees Set

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Federal Register notice: FDA announces the fiscal year 2019 rates for generic drug program areas.

2 New Drug Quality Metric Programs

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CDER director Janet Woodcock and Office of Pharmaceutical Quality director Michael Kopcha describe two new voluntary quality metri...

FDA Clears Carbon Fiber Pedicle Screw System

[ Price : $8.95]

FDA clears a CarboFix 510(k) for the CarboClear Carbon Fiber Pedicle Screw System, a device intended to surgically treat oncologic...