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FDA Releases

Created:   7/29/2011
Contains:  57 items

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FDA Approves First 3D-Printed Epilepsy Drug Experts Assess the Benefits and Caveats

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It's A First — Parent Advocacy Group Offers FDA Guidance Document on Clinical Trials for Duchenne Muscular Dystrophy

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Is the FDA's Newly Approved Transcutaneous Electrical Nerve Stimulation Device for Migraine Ready for Primetime?

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What Does FDA's ‘Breakthrough’ Pathway Mean for Neurology?

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FDA to 23andMe: ‘Stop Marketing Genetic Tests’

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FDA Approves Two New Treatments for Patients with Uncontrolled Seizures

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Free Myasthenic Syndrome Drug Program Threatened in Race for FDA Approval

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In A Game Change, FDA Shifts Criteria for Drug Development to Early-Stage Alzheimer's Disease

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FDA Warns US Practices Against Using Unapproved Foreign Botox

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Debate on FDA Policy: How Should Training on Prescribing Long-acting Opioids Be Handled?

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FDA Approves Clobazam for Reducing Lennox-Gastaut Seizures

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FDA Committee: Rasagiline Rejected as ‘Disease Modifying’ for Parkinson Disease

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FDA Asks for More Data on Sumatriptan Patch, But Neurologists Still See Promise for Migraineurs

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IOM: FDA Needs to Replace Fast-Track Approvals Process for Medical Devices

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FDA Approves Ezogabine for Partial Seizures in Adults

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FDA Alert: Curtail High-Dose Simvastatin to Avoid Myopathy

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Medical Watchdog Groups Asks FDA to Withdraw Donepezil 23 Mg

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FDA Workshop: Guidance Offered for Evaluating Devices for Seizure Detection, TBI/Concussion and Cognitive Function

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FDA Approves New System for Brain Aneurysm Repair

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FDA Approves Device for Glioblastoma Therapy

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FDA Warns That Topiramate Could Cause Birth Defects: What to Tell Patients

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Should the FDA Rescind the Humanitarian Exemption for DBS?

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DaTscan Approved for Dopamine Transporter Imaging; Skeptics Doubt Clinical Value

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FDA Approval Sought for Rivaroxaban to Prevent Stroke in Atrial Fibrillation

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FDA Panel Recommends New Imaging Agent for AD Detection

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FDA Approves Everolimus for Tuberous Sclerosis Based on Six-Month Open Label Trial

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FDA Approves Botulinum A Toxin for Severe Chronic Migraine: Training on How and When To Use is Key, Experts Say

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FDA Panel Unanimously Recommends Dabigatran Approval

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FDA Approves First MS Oral Therapy

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FDA Warns Against Quinine for Muscle Cramps — Some Neurologists Ask Why

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FDA Warns Companies about DTC Genetics Tests

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By Narrow Vote, FDA Advisory Panel Recommends DBS Device for Epilepsy

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FDA Approves First Clinical Trial of Stem Cells for ALS

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FDA Clears First Embryonic Stem Cell Trial for Spinal Cord Injury

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FDA Panel Recommends Approval of Vigabatrin for Partial Complex Seizures

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FDA Approves New Drug to Treat Severe Form of Epilepsy

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FDA Approves Tapentadol for Relief of Moderate to Severe Acute Pain

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RECALL OF WEST NILE TEST PROMPTS CDC, FDA PROBE

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FDA Approves First Drug For Chorea in Huntington Disease

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Concerns Remain After FDA Meeting on Neurotoxic Effects of Pediatric Anesthesia

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Senate Bill Calls for a Beefed Up FDA

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FDA WARNS: PML LINKED TO USE OF RITUXIMAB FOR LUPUS

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FDA APPROVES NEW INDICATION FOR MS DRUG

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FDA DELAYS APPROVAL FOR PSEUDOBULBAR AFFECT DRUG

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FDA APPROVES DONEPEZIL FOR SEVERE DEMENTIA – EXPERTS QUESTION WHY

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FDA APPROVAL OF RISPERIDONE GETS MIXED REVIEWS FROM AUTISM EXPERTS

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FDA APPROVAL OF RISPERIDONE GETS MIXED REVIEWS FROM AUTISM EXPERTS

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FDA DECISION TO APPROVE NEW DEVICE FOR DEGENERATIVE DISC DISEASE DRAWS DEBATE

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FDA CONSIDERS GUIDELINES FOR ADAPTIVE TRIALS

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FDA ADVISORY ON TRIPTANS AND SSRI/SNRIS WILL NOT AFFECT MIGRAINE TREATMENT, SAY EXPERTS

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FDA ADVISORY ON TRIPTANS AND SSRI/SNRIS WILL NOT AFFECT MIGRAINE TREATMENT, SAY EXPERTS

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MARIJUANA AS MEDICINE: DESPITE DISMISSAL FROM FDA, THE DEBATE CONTINUES

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RIVASTIGMINE FOR PARKINSON DISEASE DEMENTIA: IS FDA APPROVAL WARRANTED?

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INCREASED VIGILANCE URGED ON RISK OF PSYCHOSIS WITH ADHD DRUGS

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FDA PANELISTS OFFER INSIDE TRACK TO DECISION ON NATALIZUMAB

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ON FDA POLICY ON ANTIPSYCHOTICS AND OTHER DRUGS, EXPERTS SAY ‘SHOW US THE DATA’

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NEW AMENDMENT AIMS TO CURB CONFLICTS OF INTEREST AT FDA, BUT DOES IT GO FAR ENOUGH?

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