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Results: 11-20 of 82

ICH guidance on non-clinical studies on anti-cancer pharmaceuticals
  • Reed Smith LLP
  • USA
  • March 15 2010

FDA has released a new guidance from the International Conference on Harmonization (ICH) entitled "S9 Nonclinical Evaluation for Anticancer Pharmaceuticals."


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FDA draft guidance on adaptive design clinical trials for drugs and biologics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FDA has issued a draft guidance document to help sponsors plan and conduct adaptive design clinical studies, and to aid agency staff in the efficient FDA review of such data


FDA draft guidance on non-inferiority clinical trials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FDA has released a draft guidance document addressing the interpretability of non-inferiority (NI) clinical trials, as well as the proper approaches for determining the NI margin and analyzing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


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FDA issues draft guidance document on manufacturer communications to health care providers
  • Reed Smith LLP
  • USA
  • November 29 2010

FDA has released for comment a draft guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information."


FDA guidance on enforcement of regulations restricting sale and distribution of cigarettes & smokeless tobacco
  • Reed Smith LLP
  • USA
  • May 13 2010

FDA has issued a guidance document entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco."


FDA experimental study of patient information prototypes
  • Reed Smith LLP
  • USA
  • May 13 2010

FDA seeks public comment on a study being conducted by the agency that is designed to test different ways of presenting information about prescription drugs to patients


FDA draft guidance on occurrence of suicidality in clinical trials
  • Reed Smith LLP
  • USA
  • September 17 2010

FDA has issued a draft guidance entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials," which is intended to help sponsors to prospectively assess the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products