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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 59

12 September 2007

BD Announces FDA 510(K) Submission Of Rapid Molecular Test To Identify Patients Carrying Staph Superbug Prior To Surgery

Medical Services International Inc. Completes Testing For European Union (EU) Application

11 September 2007

Rep. Waxman Says Generic Biotech Drug Legislation Likely Will Not Reach House Floor This Year

Pfizer And FDA Warn Of Potential Carcinogen Impurity In HIV Drug Viracept

Physicians With Low Communication Scores On Exams More Likely To Receive Complaints From Patients To Regulatory Authorities

ADVENTRX Announces ANX-514 Clinical Development Plan Affirmed By The FDA

AGA Medical Corporation Receives Approval For The AMPLATZER Muscular Ventricular Septal Defect Occluder

Accuray Receives FDA Clearance For New Dose Calculation Technique For Body Radiosurgery

10 September 2007

FDA Panel Recommends Approval Of Merck's Antiretroviral Raltegravir

FDA Receiving Many More Serious Adverse Events Reports

Teva Announces Approval And Shipment Of Generic Coreg® Tablets

08 September 2007

FDA Recommends Accelerated Approval Of ISENTRESS (raltegravir), Merck's Investigational Oral Integrase Inhibitor For Treatment Of HIV

Should The Terminally Ill Have Access To Experimental Drugs?

Actavis Launches Amlodipine Tablets In The U.S.

Appropriate Pharmacovigilance Needed For The Developing World

07 September 2007

FDA Approves First Generic Versions Of Coreg

Biopure Reports On Meeting With The FDA

Ranbaxy Gains Approval To Manufacture And Market Carvedilol Tablets In The U.S. Market

06 September 2007

FDA Releases Review Of Merck's Antiretroviral Raltegravir Ahead Of Panel Meeting To Determine Whether Drug Should Be Approved

Despite More Cancer Drugs In R&D, Overall U.S. Approval Rate Is Eight Percent, According To The Tufts Center For The Study Of Drug Development

Investigational New Drug Application For "Fat Melting" Injections Cleared By The FDA

Poniard Pharmaceuticals Receives FDA Fast Track Designation For Picoplatin For Treatment Of Small Cell Lung Cancer

Dimericine(R) Receives FDA Fast Track Designation For Treatment Of Photosensitivity In XP Patients

Alba Therapeutics Announces IND For Beta Cell Preservation In Type 1 Diabetes Using AT-1001

05 September 2007

Kenya's Pharmacy And Poison Board Approves Marketing GlaxoSmithKline's HPV Vaccine Cervarix

GlaxoSmithKline's Arixtra Receives European Authorisation For The Treatment Of Acute Coronary Syndromes

FDA Approves Second-Generation Smallpox Vaccine

Investigational New Drug Application For 'Fat Melting' Injections Cleared By The FDA

04 September 2007

FDA Approves New Drug To Treat Rare Disease, Acromegaly

Merck Applies To Extend Use Of Erbitux For 1st-Line Colorectal Cancer

01 September 2007

Genetic-Screening Guidelines For Cancer Drug Questioned

ISPE Releases Good Practice Guide For Biologics

FDA Accepts For Review Complete Response To Approvable Letter For Entereg®(Alvimopan) For POI

31 August 2007

Fast And Cost Effective Test For Safer Water

Velcade Finally Approved, But Disappointment For Myeloma Patients As NICE Move The Goalposts, UK

FDA Approves Second West Nile Virus Screening Test For Donated Blood And Organs

AstraZeneca's Once-Daily SEROQUEL XR Extended-Release Tablets Approved In Netherlands For The Acute And Long Term Treatment Of Schizophrenia

RTX Healthcare Receives FDA 510k Market Clearance For Telehealth Monitor

New Hope For Kidney Cancer Patients With HSA Approval Of Anticancer Drug Nexavar

FDA Approves Human Thrombin For Topical Use In Surgery

30 August 2007

Is NICE's Cost Effectiveness Threshold Too High? UK

Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance

29 August 2007

FDA Regulations On Ozone Depleting Drugs Will Impact Availability Of Combivent

FDA Clearance Received For First Cervical Artificial Disc

FDA Proposes New Rule For Sunscreen Products - Highlights Include New UVA Rating System, Sun Warning Information

FDA Approves New Roche West Nile Virus Blood Screening Test

28 August 2007

Health Effects Of Plastic Water Pipes Investigated And Their Effect On Water Quality And Odor

GE Healthcare Announces FDA Approval For Mobile Mammography Screening Device

U.S FDA Approves GE Healthcare's Newest Mobile Mammography System For Improved Access To Breast Care

27 August 2007

More Retail Clinics Opening Nationwide; Regulators Looking At Concerns

Barr Laboratories' Plan B Earnings Remain High Despite Critics' Efforts To Reverse FDA Authorization For Nonprescription Sales

Response By American College Of Medical Genetics To New FDA Labeling Decision For Warfarin

FDA Approves Antipsychotic Risperdal For Use In Some Children

24 August 2007

FDA To Set New Standards For Sunscreens

23 August 2007

FDA Approves Antipsychotic Risperdal For Adolescents And Children

FDA Approves RISPERDAL(R) To Treat Adolescents With Schizophrenia And Children And Adolescents With Bipolar Mania

22 August 2007

FDA Rejects More New Medications This Year Than In 2006 As Agency Faces Scrutiny Over Drug Safety

FDA Warns Breast-Feeding Women Taking Codeine About Possible Overdose Risk For Infants

Aclasta Receives US FDA Approval As First And Only Once-Yearly Treatment For Women With Postmenopausal Osteoporosis

Watson Receives FDA Approval For Generic Duragesic(R)

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