Pharmaceutical News 2.0

FDA - Pharmaceutical News Feed

• Noninferiority Draft Guidance to Provide Comparative Data
  The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs.
• GSK: Senate Report Ignores Data About Avandia’s Cardio Risks
  GlaxoSmithKline (GSK) is challenging a recent Senate Finance Committee report associating cardiovascular risks with GSK’s diabetes drug Avandia, saying the report contains factual errors and omissions.
• Tyvaso Application Withdrawn, Company Cites Clinical Lapses
  United Therapeutics has withdrawn its Tyvaso marketing authorization application following European regulators’ objections to company failures to comply with good clinical practices.
• Sponsors Get FDA’s Thinking on Adaptive Trial Protocols
  The FDA has proposed the first draft guidance on adaptive design protocols for clinical trials, including details for standard operating procedures (SOPs), methods for controlling bias in the studies and encouraging sponsors to have early meetings with the agency.
• District Court Accepts Plea in Data Falsification Case
  The U.S. District Court for the District of Massachusetts has accepted a former influential pain drug researcher’s guilty plea to one count of healthcare fraud for falsifying research studies.
• Legal, Technical Challenges Slow Patient Recruitment Via EHRs
  Sites using databases for research and recruiting patients through electronic health records (EHRs) are hitting legal and technical roadblocks.
• NIH, FDA Initiative Designed to Boost Success of Trials
  An initiative between the NIH and FDA to advance regulatory science could help sponsors cut clinical trial costs and boost trial success.
• FDA Proposes Rule to Curb Falsified Data in Trials
  Sponsors that learn their clinical trial data or its analysis may have been falsified must report the information to the FDA within 45 days under a new proposed rule.
• FDA May Ask for More Trials on Diabetes Risk of Statins
  Cholesterol-lowering statins may increase patients’ risk of developing diabetes 9 percent, according to an analysis that may lead the FDA to informally ask sponsors for additional studies on the potential diabetes risk.
• Devicemakers Seek Consistency in 510(k) Trial Requirements
  The FDA’s lack of consistency in device trial requirements is driving small devicemakers out of business, stakeholders told agency officials at a recent meeting on strengthening the 510(k) review process.