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  • FDA Releases Long-Awaited Draft Guidance on Clinical Trials

    The US Food and Drug Administration (FDA) has released an extensive new guidance document that one of its top drug regulatory officials says is aimed at "greatly increase[ing] the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective." Writing in a blog posting on the FDA Voice blog on 17 December 2012, FDA's Bob Temple, deputy director for clinical science at the Center for Drug Evaluation and Research (CDER), sa...
  • Report: Inefficient Clinical Trials Cost Industry Billions Each Year

    • 06 November 2012
    Inefficient clinical trials are costing pharmaceutical development companies between $4 and $6 billion each year in unnecessary expenses, claims a new study just published by the Tufts Center for the Study of Drug Development (CSDD). The problem is widespread, the report explains, affecting roughly one in five (22.3%) trials for more than $1 million per trial. A greater percentage of Phase III trials collected extraneous data (24.7) than Phase II trials (17.7%) did. So ...
  • Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits

    The US Food and Drug Administration (FDA) is preparing to conduct a survey of prescribing healthcare professionals regarding their assessment of promotional advertising generated by the pharmaceutical industry, including advertising through social media channels, according to a 10 October posting in the Federal Register . "FDA has an interest in determining the attitudes, perceptions, and opinions of healthcare professionals with prescribing authority regarding such...
  • Study: Priority Review-Approved Drugs Show Significantly More Problems Post-Approval

    More than 34% of drugs approved by Health Canada through its fast-track accelerated review framework ultimately require the addition of serious safety warnings or removal from the market, claims a new research letter published in the Archives of Internal Medicine on 8 October. The study, by Dr. Joel Lexchin, a professor at York University, looked at 434 new active substances (NASs) approved by Health Canada between 1995 and 2010 and assessed whether they later required...
  • Study: Clinical Trials Lag in Enrollment of Children

    • 02 October 2012
    Are the pharmaceutical industry and the National Institutes of Health doing enough to enroll children in clinical trials? No, claims a new study published in the journal Pediatrics and supported by the Clinical Trials Transformation Initiative (CTTI), an organization that partners with the US Food and Drug Administration (FDA) and numerous other government agencies. The study, " Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.go...
  • Biopharmaceutical Manufacturer Admits Faulty Data Reporting, Blames Contractor

    • 24 September 2012
    Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of efficacy, is plagued by faulty data it says is the result of poor work by a third-party clinical trials contractor. In its 24 September release, Peregrine said it discovered the deficient data when preparing for an end-of-phase II meeting with the US Food and Drug Administrat...
  • Pharmacovigilance Concerns Lead Group to Call for Unique Names for Biosimilars

    • 17 September 2012
    A new survey released by the Alliance for Safe Biologic Medicines (ASBM), a group supported by branded biologics companies, says that biosimilar medicines should be required to use distinct names to differentiate themselves from their innovative biologic counterparts. Biosimilar medicines are effectively generic biologics, but have some key differences relative to their chemical drug generic counterparts. For one, biologic medicines are not exactly reproducible by gene...
  • Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits

    Advertisements for over-the-counter (OTC) pharmaceutical products routinely discount the risks associated with a product instead of presenting the same "fair balance" approach mandated for prescription products, say researchers. Writing in the Journal of the American Medical Association (JAMA) , lead researcher Jeremy Greene explained that often when prescription drugs achieve OTC status, the drug's risks disappear from the advertising. "A commitment to fair balan...
  • AHRQ Plans Patient-Based Adverse Event Reporting System

    • 12 September 2012
    Adverse event reporting could become more widespread under a new system proposed by the Agency for Healthcare Research and Quality (AHRQ). In a 10 September Federal Register posting , the agency, which acts to collect and analyze data about the quality and efficiency of care in the US, said it had submitted to the Office of Management and budget (OMB) a request to approve its prototype for a Consumer Reporting System for Patient Safety Events. AHRQ said the system is...
  • Study: FDA Beats EU Counterparts in Approving Oncology Drugs, but Otherwise Slower

    • 06 September 2012
    A new report just published by the Tufts Center for the Study of Drug Development (CSDD) has found that the US Food and Drug Administration (FDA) is faster than its EU counterpart in approving oncology products, but slower to approve non-oncology products. The study, published 5 September, looked at approval times for oncology products relative to non-oncology products in both the US and EU. Tufts said its research found that in the US, oncology products received appr...
  • Researchers: FDA Needs to Take More Control over Postmarketing Studies

    The manner in which US regulators assess the safety of prescription drug products after approval is in serious need of reform, opines a trio of researchers writing in the New England Journal of Medicine (NEJM) . The authors, Michelle Mello, Steven Goodman and Ruth Faden-all of whom were associated with the Institute of Medicine's (IOM) May 2012 report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs -argue that scientific and ethical issues...
  • Regulators to Study use of Composite Scores in Drug Advertising

    Regulators at the US Food and Drug Administration (FDA) are planning to conduct a study on consumers' understanding of composite endpoint scores used in direct-to-consumer (DTC) advertising. Composite scores are essentially a collection of clinical endpoints combined into a single overall score. An allergy drug might, explains FDA, use a composite score that measures a patient's runny nose, congestion, nasal itchiness and sneezing. Do Consumers Understand What a Compo...