Regulatory Affairs News & Drug Approvals News from Medical News Today - Page 13

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Regulatory Affairs / Drug Approvals News

The latest Regulatory Affairs News & Drug Approvals News articles published daily. Includes news on FDA approvals, EMEA approvals and other regulatory issues. Category added August 2007.

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Regulatory Affairs / Drug Approvals News Articles Archive - Page 13

17 June 2009

Certain Cold Remedies Linked To Loss Of Sense Of Smell Warns FDA

Pluristem Therapeutics Receives European Regulatory Approval For Placental-Derived Stem Cell Clinical Trial

OSI Pharmaceuticals Announces Acceptance Of Tarceva Supplemental New Drug Application For Review By The U.S. Food And Drug Administration

Cameron Health Announces CE Mark Of The Minimally Invasive Totally Subcutaneous Implantable Defibrillator For Treatment Of Sudden Cardiac Arrest

16 June 2009

FDA Warns Web Sites Against Marketing Fraudulent H1N1 Flu Virus Claims

BioElectronics Is Filing For 510(k) Clearance With FDA For Its AllayTM Product

Meda: FDA Approval For Onsolis Anticipated During Summer 2009

15 June 2009

FDA Requests Labeling Change For Leukotriene Modifiers

FDA Issues Public Health Advisory Regarding Levemir Insulin

Genzyme Receives European Approval Of Renvela For Patients With Chronic Kidney Disease

NeuroLogica Corporation Receives Chinese FDA & CQC Approval To Provide Its CereTom Portable CT Scanner Throughout China

14 June 2009

Emergent BioSolutions Meets With FDA To Review Regulatory Strategy For Recombinant Anthrax Vaccine

PharmaCom BioVet, Inc. Begins To Review The Process To Potentially Receive Minor Use/Minor Species Drug Approval From FDA

CMA Applauds Senate Passage Of FDA Tobacco Rules

Medtronic Receives FDA Approval For BRYAN(R) Cervical Disc System

FDA Alerts Patients To Medtronic Pacemaker Recall

FDA Approves Injectable Form Of Ibuprofen

FDA Near To Gaining Regulatory Control Over Tobacco Products

Senate Passes Family Smoking Prevention And Tobacco Control Act - FDA To Have Unprecedented Powers To Regulate Tobacco

13 June 2009

FDA Accepts Final Section Of NDA Filing For LUCASSIN(R)

Transcept Pharmaceuticals Announces Expected FDA Extension Of Regulatory Review Period For Intermezzo(R)

12 June 2009

Senior Scientist Cautions On The Label For Homeopathic Product

Senate Will Vote On Tobacco Bill Today

VIA Pharmaceuticals Meets With FDA To Discuss Next Steps For VIA-2291 And Phase 3 Outcome Trial In Cardiovascular Disease

FDA Advisory Committee Votes In Favor Of Zyprexa For Two Adolescent Indications

STAAR Surgical Receives FDA Clearance For The Epiphany(TM) Injector System

FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination

Emergent BioSolutions Receives FDA Approval Extending Shelf Life Of BioThrax (Anthrax Vaccine Adsorbed) To 4 Years

FDA Classifies Previously Announced Medtronic Physician Advisory On Small Subset Of Kappa And Sigma Pacemakers As Class I Recall

Kai Sensors Receives FDA Clearance For Its Wireless, Non-Contact Respiratory Device

11 June 2009

EyeIC Receives FDA 510(k) Clearance For MatchedFlicker(TM) Retinal Aid Detection Technology

MonoSol Rx Announces FDA Acceptance Of NDA For Ondansetron Orally Dissolving Film Strip

Strativa's New Drug Application For Ondansetron Orally Dissolving Film Strip Accepted By FDA

NeurogesX Provides U.S. Regulatory Update For Qutenza(TM)

SVS 2009: Ziehm Imaging Sets A New Standard In Mobile Imaging With The Ziehm Vision RFD

Exposure To Controversial Chemical May Be Greater Than Dose Considered Safe

Stellar Pharmaceuticals Inc. Announces Watson Pharma, Inc. Has Received A Conditional IDE Approval For Stellar's Uracyst(R) From The FDA

10 June 2009

Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD™, An Investigational Treatment For Mixed Dyslipidemia

Senate Could Vote Today On Tougher Tobacco Legislation

Results From Phase 1 Clinical Study Of PEG-PAL In PKU And Update On Phase 2 Clinical Study

MDRNA, Inc. Receives Full FDA Approval Of Generic Calcitonin-Salmon Nasal Spray For Osteoporosis

09 June 2009

FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug

FDA Warns Consumers Not To Use Skin Products Made By Clarcon Due To Bacterial Contamination Risk

PanGenetics Receives Approval For Clinical Evaluation Of Anti-NGF Antibody In Patients With Chronic Pain

VeroScience Presents Data On Newly FDA Approved Drug Cycloset At American Diabetes Association Annual Scientific Sessions

Diamyd(R) Phase III Study Approved For Younger Patients In The US

Research: Popular Diabetes Medications Associated With Increase In Bone Fractures

D-Pharm Receives FDA Clearance To Commence A Phase III Trial Of DP-b99 In Acute Stroke Patients

08 June 2009

Dysport(R) Cosmetic Injection - For Erasing Wrinkles - Receives U.S. FDA Approval

Health Canada Approves Innovotech Application For AgressTM Field Testing

Idaho Technology Gains Army Approval Of Platinum Path™ Extraction Kit For Biological Pathogen Detection Program

06 June 2009

Palomar Receives FDA Over-The-Counter Clearance For A Home Use Wrinkle Removal Laser Device

Why Don't All Insurance Plans Cover Ankle Replacements When The FDA Has Approved Them?

05 June 2009

FDA Approves First Canine Cancer Therapy

CE Mark Extended For Disc Dynamics' DASCOR(R) Disc Arthroplasty System

Advaxis Receives FDA Response To Orphan Drug Filing

Meridian Bioscience Receives FDA Clearance For New Rapid Campylobacter Test

FDA Warnings About Antidepressants Associated With Lasting, Unintended Changes In Diagnosis And Treatment

Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD(TM), An Investigational Treatment For Mixed Dyslipidemia

Anti-Thyroid Drug Linked To Serious Liver Injury Warns FDA

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