Pharmaceutical News 2.0

FDA - Pharmaceutical News Feed

• Debate Over GSK’s Avandia Focuses on Trial Data, Use of Meta-Analyses
  The debate over Avandia could have far-reaching consequences for other drug sponsors as the crux of the controversy focuses on clinical trial data and their interpretation in meta-analyses.
• IOM Report: Informed Consent Should Be an Ongoing Process Throughout a Trial
  The “kitchen sink” approach to informed consent should give way to an ongoing process that is adjusted as necessary throughout a clinical trial, the Institute of Medicine (IOM) recommends in an interim report to the FDA.
• OIG Calls for More Oversight of Foreign Clinical Trials
  More than half of all clinical trials for FDA-regulated drugs and biologics were conducted outside the U.S. in fiscal 2008, yet the agency inspected fewer than 1 percent of foreign trial sites, a report by the HHS Office of Inspector General (OIG) concludes.
• Citing Confirmatory Trials, Panel Votes No on Avastin
  An FDA advisory panel voted overwhelmingly to recommend removing an indication for Genentech’s Avastin as a first-line treatment for metastatic breast cancer (MBC).
• ACRO: Proposed HHS Rule Balances Research Access, Patient Privacy
  HHS’ proposed privacy rule that loosens restrictions on clinical trials strikes an appropriate balance between a researcher’s need for access to health information and protection of a subject’s privacy, according to the Association of Clinical Research Organizations (ACRO).
• FDA Guidance Sets Endpoint for Lupus Clinical Trials
  Drugmakers developing products for the treatment of systemic lupus erythematosus (SLE) should use a disease activity index such as the British Isles Lupus Assessment Group as the primary efficacy endpoint in clinical trials, a new guidance says.
• Diverse EU Insurance Regulations Cause Delays in Clinical Trials
  A hodgepodge of liability insurance requirements is keeping some device sponsors from starting clinical trials on time in the EU, delaying the approval process.
• Site Contract Breaches May Invite an Inspection, Data Invalidation
  Breaches of a trial contract can result in an FDA inspection and invalidate the data gathered at a trial site, a former FDA official says.
• Managing Risk in Clinical Trials Best Defense Against Lawsuits
  One of the rising costs sponsors face in bringing a new medical product to market stems from lawsuits involving clinical trials.
• New Guidance Details Conditions for Using Foreign Data for PMA
  Data from foreign clinical studies can be used as the sole support of a premarket approval (PMA) for an in vitro diagnostic (IVD) as long as the data meet specific criteria, the FDA says in a new guidance.