Policy & Regulation: Page 29

  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Shifting the Compliance Paradigm

    VIEW on regulatory compliance Michael Kuehne is President of ACSYS Inc., Hillsborough, N.J., which specializes in developing quality and compliance solutions that combine R&D and manufacturing capabilities to deliver sustained improvement in R&D, Quality, Operations, Clinical, and Regulat...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Medicare

    Medicare Campbell. Executives will continue to prepare for the new regulations approved under the Medicare Prescription Drug, Improvement and Modernization Act (MMA). These regulations will take effect as scheduled on Jan. 1, 2006. Before the full benefit’s official start, however, the industry f...

    By PharmaVoice Team • Jan. 2, 2008
  • drug shopping cart Explore the Trendline➔
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    Trendline

    Commercialization, marketing and social media

    As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical. 

    By PharmaVoice staff
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Regulatory

    FDA Acts to Strengthen the Safety Program for Marketed Drugs On Nov. 5, 2004, Acting FDA Commissioner Dr. Lester M. Crawford issued the following statement: Modern drugs provide unmistakable and significant health benefits, but experience has shown that the full magnitude of some potential risks ...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Culture of Compliance: Cutting Through the Confusion

    Culture of Compliance: Cutting Through the Confusion A few years after the Pharmaceutical Research and Manufacturers of America (PhRMA) code and the Office of the Inspector General (OIG) guidance, and the more recent implications of the Accreditation Council for Continuing Medical Education (ACCM...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's on Your Mind -- Opinions

    What’s on your Mind Opinions Monitoring Drug Safety The industry and the U.S. Food and Drug Administration have come under significant scrutiny since Merck’s withdrawal of Vioxx. Six papers on the issue were published on the subject in the Dec. 1, 2004, issue of the Journal of the American Medica...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Cautious Capital

    The funding environment for biotech and start-up companies has improved considerably during the past few years. But venture capital investors are more cautious and more demanding than ever before. Karen Boezi Venture capital investors will increasingly be focused on capital efficiency and reducin...

    By Lisa Dress • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    PharmaTrax

    Pharma Trax Sales, Marketing, And R&D Trends Affecting the Healthcare Industry Doctors Prefer Details by Specialty Reps In the past three years, specialty sales representatives have become an increasingly important promotional investment for pharmaceutical companies, according to Verispanís l...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Pharmacogenomics: The Next Step Forward

    Pharmacogenomics The Next Step Forward The first NDA based on pharmacogenomic data may still be a long time coming, but in anticipation of such filings, the FDA has issued a draft guidance that encourages companies to conduct pharmacogenomic tests during the drug-development process. Pharmacogeno...

    By Denise Myshko • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Sea Change

    Sea Change Turning the tide The Product Life-Cycle Management Wave Commonly thought of as a strategy for the end-phase of a drug, life-cycle management increasingly is being deployed by life-sciences executives earlier in the development phases to maximize product value, provide greater benefits ...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    PharmaOutlet

    Contributed by Harry Sweeney Back to the Future Credit the Food and Drug Administration with showing up in force and spelling out its intentions clearly at Parade Magazine’s Direct-to-Consumer Advertising Draft Guidance Symposium in New York City in one of the most collegial sessions I’ve attende...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Talent Pool

    Talent Pool Executive Appointments and Promotions in the Healthcare Industry Pharma POOL Dr. Vijay Aggarwal David Hurley aaiPharma Announces Two Executive Promotions aaiPharma Inc. has appointed Dr. Vijay Aggarwal, formerly president of AAI Development Services, to the role of president, research...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    E-Submissions: On the Brink of Going Paperless

    E-submissions On the Brink of Going Paperless By Denise Myshko The shift from static paper regulatory applications to dynamic and interactive electronic submissions will make data more accessible to reviewers and, ultimately, improve the efficiency of the review process. December 15, 2004, was a ...

    By Denise Myshko • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's New

    What’s new New healthcare-related products, services, and companies PRA forms Global Medical and Safety Services Division The new business unit consolidates PRA’s risk-management activities across the company. PRA International, a clinical research organization, has formed Global Medical and Safe...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    The Medical Affairs-Marketing Connection

    The Medical Affairs-Marketing Connection By Denise Myshko A changing regulatory environment is mandating that there is better collaboration between the medical affairs and marketing departments of pharmaceutical companies. These two groups are forging stronger relationshiPS for better product lif...

    By Denise Myshko • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Raising Standards to Reduce Pressure

    By Elisabeth Pena Raising Standards to Reduce Pressure Last year, the landscape for hypertension medications was sHAKEN by study results and guideline recommendations. But despite all the noise, has anything changed in this market? In the last quarter century, a number of new medications have bee...

    By Elisabeth Pena • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Marsha Fanucci: A Team Builder

    By Kim Ribbink Team People make an organization. For Marsha Fanucci, Senior VP of Finance and Corporate Strategy at Millennium Pharmaceuticals Inc., building a quality team capable of propelling a company forward is the best measure of success. MARSHA Fanucci rom pharmaceutical consulting to star...

    By Kim Ribbink • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    E-Media

    E-Media New electronic and web-based applications, sites, and technologies Ness Technologies’ life-sciences division has introduced a new service offering, Ness SmartSourcing For Life Sciences, which allows life-sciences companies to combine the benefits of IT services, offshoring, and outsourcin...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    2nd Chances

    2nd Chances By Elisabeth Pena For products that are not performing to expectations, a relaunch can revitalize a stale brand, highlight new clinical evidence, or give a product another chance to reach the patients it was designed to treat. With each therapy that a pharma company produces, the goal...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Talent Pool

    Pharma POOL Richard W. Ashley James White Abbott Laboratories Names New Executives Abbott Laboratories has named Richard W. Ashley to the new position of executive VP of corporate development. Abbott, Abbott Park, Ill., is a global, broad-based healthcare company devoted to the discovery, develop...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    E-Media

    E-Media New electronic and web-based applications, sites, and technologies NoInk Communications has released Pharma-SalesAccelerator, a new suite of applications specifically designed to improve productivity and increase performance of pharmaceutical sales organizations. NoInk partnered with Pedi...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Talent Pool

    Talent Pool Executive Appointments and Promotions in the Healthcare Industry Pharma POOL Eileen M. Lach Wyeth Fills VP, Associate General Counsel Position Wyeth has promoted Eileen M. Lach to the position of VP, corporate secretary, and associate general counsel. Wyeth, Madison, N.J., is a pharma...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's on Your Mind -- Opinions

    What’s on Your Mind — Opinions More on the New DTC Guidelines PharmaVOICE received an overwhelming number of responses to our January opinion question, which addressed the FDA proposed changes to the regulations that govern the content and format of the product disclaimer or brief summary that mu...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Table of Contents

    Table of Contents Download PDF

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's New

    What’s new New healthcare-related products, services, and companies Ventiv Health expands Services Ventiv Health has launched Ventiv Recruitment Services as a stand-alone option to provide clients with targeted, highly effective sales professionals across many therapeutic areas. “Specialty pharma...

    By PharmaVoice Team • Jan. 2, 2008
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    PharmaTrax

    Pharma Trax Sales, marketing, And R&D Trends affecting the healthcare industry Medicare Reform to Result in More Use of Drugs As early as 2006, the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) is expected to provide $10 billion to $15 billion in new drug spendin...

    By PharmaVoice Team • Jan. 2, 2008