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Results: 11-20 of 82

New Molecular Entity Postmarketing Safety Pilot Program
  • Reed Smith LLP
  • USA
  • October 30 2009

FDA has completed the "New Molecular Entity Postmarketing Safety Evaluation Pilot Program" that began in January, 2007


FDA listing of drugs with potential safety issues
  • Reed Smith LLP
  • USA
  • February 26 2010

On February 18, 2010, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System


FDA meeting on the development of drugbiological names, labels and packaging
  • Reed Smith LLP
  • USA
  • April 15 2010

FDA will hold a public meeting entitled "Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors" on June 24-25, 2010 in Bethesda, Maryland


FDA draft guidance on adaptive design clinical trials for drugs and biologics
  • Reed Smith LLP
  • USA
  • March 15 2010

FDA has issued a draft guidance document to help sponsors plan and conduct adaptive design clinical studies, and to aid agency staff in the efficient FDA review of such data


FDA draft guidance on non-inferiority clinical trials
  • Reed Smith LLP
  • USA
  • March 15 2010

FDA has released a draft guidance document addressing the interpretability of non-inferiority (NI) clinical trials, as well as the proper approaches for determining the NI margin and analyzing results


FDA guidance intended to bolster vaccine development
  • Reed Smith LLP
  • USA
  • March 15 2010

FDA has issued a final guidance entitled "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications."


FDA announces Safe Use initiative for drug products
  • Reed Smith LLP
  • USA
  • December 4 2009

The Food and Drug Administration (FDA) has announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use


GAO report calls for increase in FDA criminal prosecutions of company executives
  • Reed Smith LLP
  • USA
  • March 15 2010

The GAO recently issued a report entitled "Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations," at the request of Senate Finance Committee Ranking Republican Charles Grassley


FDA requests comments on increasing transparency in the agency
  • Reed Smith LLP
  • USA
  • March 15 2010

As part of the Obama Administration's efforts to increase transparency in government, FDA is soliciting comments on ways to increase transparency between FDA and regulated industry


FDA issues final regulations requiring the submission of information on pediatric populations for devices
  • Reed Smith LLP
  • USA
  • April 16 2010

The Food and Drug Administration (FDA) has issued a direct final rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients