Policy & Regulation: Page 27

  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    A More Efficient FDA for the Device World

    A More Efficient FDA for the Device World By Denise Myshko Quicker review times are an expected result of user fees, but in the device industry they provide a valuable resource as the sector employs technological advances as part of its submissions. If user fees work for prescription drugs, they ...

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

    Accurately Costing a Clinical Trial

    Accurately Costing a Clinical Trial By Denise Myshko Streamlining the budget process not only leads to more accurate resource allocation, it also allows for better predictions and creates more accurate clinical-trial planning. July 2003 Clinical-trial spending has increased considerably over the ...

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

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

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

    Advocacy Relations: Finding Common Ground

    Advocacy Relations: Finding Common Ground Forum By Elisabeth Pena Villarroel Where patient health is concerned, the goals of pharmaceutical companies and advocacy groups intersect. Teri Cox Cox Communications Partners People know about Breast Cancer Awareness Month and Prostate Cancer Awareness M...

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

    Clinical Data Strategies for Performance Optimization

    Octagon Research Solutions Inc. Data Standards Organizations that hesitate to embrace these standards as opportunities will be at a competitive disadvantage. They will continue to struggle with the tactical “cost” of transforming the ...

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

    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies E-Media June 2005 PharmaVOICE SAS Upgrades Scientific Discovery Solutions In response to the need for modernization in the drug-development process, SAS Institute Inc. has made significant upgrades and additions to its Scientific ...

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

    E-Media

    November 2003E-media MDS Pharma Express is intuitive, user-friendly, and designed to operate with minimal computer requirements and the highest level of Internet security –providing easy access to current study status information in real time, anytime. MDS Electronic Data-Delivery System Allows f...

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

    The Continuing Evolution of EDC

    Paper may still reign supreme, but the EDC industry is coming of age. There is widespread agreement — at least intuitively — that the use of an electronic device or software application that allows direct data entry into electronic format has the potential to reduce time and money within the drug...

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

    After They Walk Out the Door

    After They Walk Out the Door By Elisabeth Pena Pharmaceutical companies recognize that direct-to-consumer campaigns have to address compliance with treatment regimens if they are to hold on to patients after they leave the doctor’s office. The messages in direct-to-consumer advertising are shifti...

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

    Dr. Sidney Pestka -- A Father of Invention

    Dr. Sidney Pestka — A Father of Invention by Kim Ribbink With a wealth of discoveries and other scientific achievements to his name, Sidney Pestka, Ph.D., has positioned his company — PBL Biomedical Laboratories and its subsidiary PBL Therapeutics — to lead the charge in cutting-edge research. Si...

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

    What's New

    Society of Hospital Medicine Launches New Medical Journal The Society of Hospital Medicine plans to launch a new peer-reviewed medical journal, The Journal of Hospital Medicine, in 2006. The journal will promote the science and practice of hospital medicine and the enhancement of in-patient care....

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

    Talent Pool

    Pharma POOL Kevin Guthrie Thom Rowland Solvay Promotes VPs Solvay Pharmaceuticals, Marietta, Ga., a pharmaceutical company focused on cardiology, gastroenterology, mental health, women’s health, and select specialized markets, has promoted Kevin Guthrie to VP of commercial operations, neuroscienc...

    By PharmaVoice Team • Jan. 2, 2008
  • 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
  • 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