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Regulatory in Medical News

Novo Nordisk Appoints Per Falk, M.D., Ph.D., as Vice President for Clinical, Medical and Regulatory Affairs for North America

PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Novo Nordisk, a global healthcare company focusing on diabetes care, today announced the appointment of Per Falk, M.D., Ph.D., as vice president for Clinical, Medical and Regulatory Affairs for North America. Dr. Falk joins the U.S. Executive ...

Validation & Compliance Institute, LLC, to Provide Medical Device Regulatory Training for the University of Michigan's Medical Innovation Center

ANN ARBOR, Mich., Aug. 3 /PRNewswire/ -- Validation & Compliance Institute (VCI) is developing a series of training videos for the University of Michigan Medical Innovation Center (MIC). The videos will introduce University of Michigan researchers to the regulations that are required by ...

CSC's FirstDoc Recognized by EMC as a Preferred Regulatory Compliance Application for Life Sciences Industry

FALLS CHURCH, Va., July 30 /PRNewswire/ -- CSC (NYSE: CSC ) today announced an agreement with EMC Corporation to offer advanced compliance solutions to the life sciences industry. As part of the agreement, EMC will now offer CSC's FirstDoc as a preferred regulatory compliance...

Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product

CARY, N.C., July 15 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc. (Nasdaq: CRTX ), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that it has submi...

NeoStem, Inc. Appoints International Expert in Endocrinology and Pharmacology as Vice President of Drug Development and Regulatory Affairs

NEW YORK, July 6 /PRNewswire-FirstCall/ -- NeoStem, Inc. (Amex: NBS ), which is pioneering the pre-disease collection, processing and long-term storage of adult stem cells for future medical need, announced today it has appointed Alan G. Harris, M.D., Ph.D., FACP, FRCP, as the Company's Vice Pre...

Saint Vincent Health Center Ensures Regulatory Compliance with SIS

ATLANTA, June 23 /PRNewswire/ -- Each year hospital operating rooms face increasingly difficult challenges as patient safety requirements from regulatory agencies grow more demanding. Saint Vincent Health Center (SVHC) in Erie, PA uses a perioperative automation solution, Sunrise Surgery(TM), pro...

Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo(R)

RICHMOND, Calif., June 11 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT ) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new...

LCA Applauds Senate Leadership Team Working to Secure New FDA Regulatory Authority Over Tobacco

WASHINGTON, June 3 /PRNewswire-USNewswire/ -- Today, Lung Cancer Alliance (LCA) attended a press conference held by the Senate leadership team guiding consideration of historic legislation that would give the U.S. Food and Drug Administration (FDA) regulatory authority over tobacco products. ...

Transatlantic Regulatory Integration of Drug Approval Process Vital for the Global Pharmaceutical Industry, Notes Frost & Sullivan

LONDON, May 19 /PRNewswire/ -- Regulatory processes differ across continents, posing challenges to drug launches. There is a pressing need to integrate the regulatory environment of the European Union (EU) and the U.S. Diverse regulations impact drug launches as less price controlled markets witne...

Beckman Coulter Pending Acquisition of Olympus Diagnostics Systems Passes Milestone with U.S. Regulatory Approval

ORANGE COUNTY, Calif., May 13 /PRNewswire-FirstCall/ -- Beckman Coulter, Inc. (NYSE: BEC ), a leading developer, manufacturer, and marketer of products that simplify, automate, and innovate complex biomedical testing, today announced that the Federal Trade Commission has terminated its review un...

Blue Mountain Quality Resources Announces that Cepheid has Selected Blue Mountain Regulatory Asset Manager

STATE COLLEGE, Pa., May 12 /PRNewswire/ -- Blue Mountain Quality Resources announced today that Cepheid has chosen Blue Mountain Regulatory Asset Manager for use in their manufacturing facilities. "By bringing together calibration and maintenance management into a single platform, Blue...

Bobbi Drais Promoted to Vice President, Regulatory Affairs for HEALTHPOINT, Ltd.

FORT WORTH, Texas, May 7 /PRNewswire/ -- HEALTHPOINT, Ltd., a DFB Pharmaceuticals, Inc. company, has announced the promotion of Bobbi Drais to Vice President of Regulatory Affairs. Ms. Drais, with 15 years of regulatory experience, was most recently Senior Director of Regulatory Affairs for th...

Higher Outlays and Improved Regulatory Enforcement Create Opportunities in the Kenyan Healthcare Industry, Reveals Frost & Sullivan

CAPE TOWN, South Africa, May 5 /PRNewswire/ -- Increased public and private expenditure on healthcare, coupled with increasing levels of medical insurance coverage and continued foreign donor funding are creating significant opportunities for growth within the Kenyan healthcare industry. The pharm...

Solta Medical Receives Regulatory Approval to Market Thermage Systems in China

HAYWARD, Calif., April 30 /PRNewswire-FirstCall/ -- Solta Medical, Inc. (Nasdaq: SLTM ), a global leader in the medical aesthetics market, today announced that it has received regulatory clearance to market and sell Thermage(R) systems in China. "We are excited about the opportunity to market t...

HIPAApedia.com Goes Live - The First Dedicated Educational Community Wiki Aimed at Healthcare Information Professionals Interested in HIPAA Regulatory Issues and Solutions.

BELLEVUE, Wash., April 27 /PRNewswire/ -- HIPAApedia.com, the first dedicated educational community wiki to serve the healthcare IT community and business professionals interested in HIPAA regulatory issues and solutions, is now available. Sponsored by Edifecs, the leader in providing healthcare ...

ATS Medical Announces Regulatory Approval of the ATS Open Pivot AP360 Mechanical Heart Valve in Japan

MINNEAPOLIS, April 16 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced the Japanese Ministry of Health, Labor and Welfare has approved commercial distribution of the ATS Open Pivot(R)...

Lionbridge Announces Partnership with Open Text to Streamline Regulatory Compliance Solutions for Pharmaceutical Companies

WALTHAM, Mass., April 13 /PRNewswire-FirstCall/ -- Lionbridge Technologies, Inc. (Nasdaq: LIOX ), a leading provider of translation, testing and development services today announced an alliance with Open Text Corporation, a global leader in Enterprise Content Management (ECM) software, desig...

Xoft Receives Health Canada Regulatory Approval for the Axxent(R) Electronic Brachytherapy System

Xoft Also Achieves ISO Certification for Quality Manufacture of the Axxent(R) System SUNNYVALE, Calif., April 9 /PRNewswire/ -- Xoft, Inc., pioneers in the field of micro-miniature X-ray sources for medical treatment, announced today that it has been granted a medical device license by the ...

RAPS Offers New International Regulatory Affairs Certification - RAC (GS)

New RAC Credential Focuses on General Scope of Regulatory Practice, International Standards ROCKVILLE, Md., April 7 /PRNewswire-USNewswire/ -- The Regulatory Affairs Professionals Society (RAPS) has announced its newest Regulatory Affairs Certification (RAC), the RAC General Scope (GS). The...

Berlin Heart Receives First Regulatory Approval in North America

BERLIN, April 3 /PRNewswire/ -- Berlin Heart GmbH today announced it has received its first marketing approval in North America. The EXCOR(R) Pediatric ventricular assist device received the License with Conditions from Health Canada, the Federal Department responsible for regulatory issues in...

U.S. House of Representatives Again Votes with a Strong Bipartisan Majority in Favor of Granting the U.S. FDA Regulatory Control Over Tobacco Products

American Lung Association Urges Senate to Quickly Pass this Important Lifesaving Legislation WASHINGTON, April 2 /PRNewswire-USNewswire/ -- Statement of Charles D. Connor, American Lung Association President and CEO: Today in Washington, the U.S. House of Representatives overwhelmingly v...

SmartDraw Helps Hospitals Document and Standardize Processes to Achieve Greater Compliance With Regulatory Agencies

SmartDraw.com, maker of SmartDraw, the software that helps you work smarter by communicating visually, is becoming the software tool of choice for healthcare systems looking to visually document and standardize processes across hospital departments in order to meet regulatory requirements. ...

PURE Bioscience Announces Brazilian Regulatory Approval for SDC-Based Hospital-Grade Disinfectants

Life Biociencias S/A Launches Desinfetantes Hospitalar LFE 250SX and LFE 200SX to Target Hospital Acquired Infections SAN DIEGO, Feb. 19 /PRNewswire-FirstCall/ -- PURE Bioscience (Nasdaq: PURE ) today announced that its distributor in Brazil, Life Biociencias S/A (Lifebio), recently obtaine...

Musculoskeletal Clinical Regulatory Advisers, LLC Announces Signing of its 100th Client

WASHINGTON, Feb. 19 /PRNewswire-USNewswire/ -- Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), the leading musculoskeletal consulting firm focused on regulatory, clinical, intellectual property, quality assurance and reimbursement strategy development, announced today the signing of its ...

A Drug That Receives Regulatory Approval for Cognitive Impairment Associated With Schizophrenia Would Earn a Higher Patient Share in the United States Than in Europe

A Therapy's Effect on Executive Function and Functional Capacity are the Attributes that Most Influence Psychiatrists' Prescribing Habits, According to a New Report from Decision Resources WALTHAM, Mass., Feb. 17 /PRNewswire/ -- Decision Resources, one of the world's leading research and advi...

PAREXEL Consulting Enhances European Regulatory Affairs Capabilities With Appointment of Medical Products Agency Expert Dr. Anders Neil

BOSTON, Feb. 17 /PRNewswire-FirstCall/ -- PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL ) and leading global consultancy serving the biopharmaceutical and medical device industries, has appointed Anders Neil, Ph.D., to the position of Principal Consultant in its Eu...

Priligy(TM) (Dapoxetine) Receives First Regulatory Approvals for the Treatment of Premature Ejaculation (PE) in Finland and Sweden

BEERSE, Belgium, February 10 /PRNewswire-FirstCall/ -- Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., announced today that Priligy(TM) (dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18-64 ...

ATS Medical Announces Australian Regulatory Approval for ATS 3f Aortic Bioprosthesis

MINNEAPOLIS, Feb. 5 /PRNewswire-FirstCall/ -- ATS Medical, Inc. (Nasdaq: ATSI ), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced today that the Australian Therapeutic Goods Administration (TGA) has granted approval for commercialization of the A...

New Website Offers Easy Access to Breaking HealthCare News and Regulatory Compliance Information

HCPro, Inc., a portfolio company of Halyard Capital and a leading provider of education and information on healthcare regulatory compliance and management, announced today the launch of its redesigned corporate Web site for healthcare professionals, www.hcpro.com . Mar...

ProAssurance Receives Regulatory Approvals for Transactions with the PICA Group and Georgia Lawyers Insurance Company

BIRMINGHAM, Ala., Jan. 28 /PRNewswire-FirstCall/ -- ProAssurance Corporation (NYSE: PRA ) announced today that all required regulatory approvals have been granted in connection with its proposed sponsored demutualization of the PICA Group (PICA), the nation's leading provider of professional...

Johnson & Johnson Announces Satisfaction of Regulatory Clearances Condition for its Proposed Acquisition of Mentor Corporation

NEW BRUNSWICK, N.J., Jan. 15 /PRNewswire-FirstCall/ -- Johnson & Johnson (NYSE: JNJ ) today announced that all applicable foreign antitrust and similar regulatory clearances required for its cash tender offer to purchase all outstanding shares of common stock of Mentor Corporation (NYSE: M...

Wilson Sonsini Goodrich & Rosati Expands Consumer Regulatory Practice

- Hires FTC Bureau Chief Lydia Parnes - PALO ALTO, Calif., Jan. 13 /PRNewswire/ -- Wilson Sonsini Goodrich & Rosati, the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, today announced that Lydia Parnes will join the firm as a new partner...

Scientists, Physicians, Health, and Environmental Justice Advocates to New Obama EPA Director: 'We Look Forward to Toxic Chemical Regulatory Reform'

WASHINGTON, Dec. 12 /PRNewswire-USNewswire/ -- Dozens of health advocacy groups concerned about growing rates of obesity, diabetes, heart disease, cancer, reproductive and developmental problems, thyroid disease and other illness linked to chemical exposure, said today that they loo...

Savient's Board of Directors Forms a Board Committee to Oversee the Regulatory and Pre-Launch Activities for Pegloticase

Christopher Clement Resigns; Board Appoints Paul Hamelin as President EAST BRUNSWICK, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced that its Board of Directors has formed a BLA Oversight Committee ("the Committee")to oversee the re...

Alexander R. Giaquinto, Ph.D., Joins Regado Biosciences as Senior Vice President of Regulatory Affairs and Quality Assurance

BASKING RIDGE, N.J. and DURHAM, N.C., Nov. 11 /PRNewswire/ -- Regado Biosciences, Inc., today announced the appointment of Alexander R. Giaquinto, Ph.D., to the newly created position of Senior Vice President of Regulatory Affairs and Quality Assurance, effective immediately. Dr. Giaquinto bri...

New Acticoat(TM) Silver Coated Anti-microbial Barrier Dressing Receives Regulatory Approval from Health Canada

WAKEFIELD, MA, Nov. 7 /PRNewswire-FirstCall/ - NUCRYST Pharmaceuticals, a developer and manufacturer of medical products that fight infection and inflammation, and the Advanced Wound Management division of Smith & Nephew plc announced today that Health Canada granted marketing approval for Act...

Alexion Pharmaceuticals Chooses Blue Mountain Regulatory Asset Manager(R) for Best-in-class Calibration Management Integrated with SAP(R)

STATE COLLEGE, Pa., Oct. 28 /PRNewswire/ -- Blue Mountain Quality Resources, Inc. announced today that Alexion Pharmaceuticals has chosen Blue Mountain Regulatory Asset Manager(R) to satisfy their immediate and long-term calibration management needs as part of their enterprise-wide SAP(R) impl...

Cardiome Provides Regulatory Update

NASDAQ: CRME TSX: COM VANCOUVER, Oct. 9 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has been informed by its co-development partner, Astellas Pharma US, Inc., that an End of Review meeting with the U.S. Food & Drug Administration (FDA) has...

Plexus Online Enhances Functions for Medical Device Manufacturing Regulatory Compliance

AUBURN HILLS, Mich., Oct. 8 /PRNewswire/ -- Plexus Systems, Inc., provider of Plexus Online software for the medical manufacturing enterprise, today announced a set of enhancements for medical device manufacturers. The new enhancements include an integrated program that will provide enterprise...

Discoverers of Small Regulatory RNAs and Cholesterol-Lowering Drugs to Receive Lasker Awards for Medical Research

Pioneer in Understanding Harmful Bacteria Honored with Special Achievement Award NEW YORK, Sept. 13 /PRNewswire/ -- The 2008 Albert Lasker Medical Research Awards ( http://www.laskerfoundation.org ) were announced today. First presented in 1946, the Lasker Awards...
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