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Results: 11-20 of 82

FDA seeks comment on co-development of two or more investigational drugs
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA has announced plans to develop guidance and the opening of a public docket for public comment on the co-development of two or more drugs to be used in combination to treat a single disease or condition


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."


Use of Bayesian statistics in medical device clinical trials
  • Reed Smith LLP
  • USA
  • February 12 2010

In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials


Guidance on complete submissions for the evaluation of proprietary names
  • Reed Smith LLP
  • USA
  • February 12 2010

To maximize the agency's efforts to process submissions for the evaluation of proprietary names within the deadlines under the Prescription Drug User Fee Act (PDUFA), FDA issued a guidance document to assist manufacturers in making a complete submission, which is required for the PDUFA review clock to begin


FDA initiative to reduce unnecessary radiation exposure from medical imaging
  • Reed Smith LLP
  • USA
  • February 12 2010

FDA recently announced an initiative seeking to minimize patient exposure to ionizing radiation associated with computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams


Draft guidance on continuing IRB review after clinical investigation approval
  • Reed Smith LLP
  • USA
  • February 12 2010

A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the criteria, process, and frequency of continuing IRB review necessary to ensure that subjects in clinical trials are protected


FDA draft guidance on occurrence of suicidality in clinical trials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FDA has issued a draft guidance entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials," which is intended to help sponsors to prospectively assess the occurrence of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


FDA draft guidance on electronic source documents in clinical trials
  • Reed Smith LLP
  • USA
  • January 13 2011

FDA has published a draft guidance entitled "Electronic Source Documentation in Clinical Investigations."


FDA publishes draft guidance on reprocessing of reusable medical devices
  • Reed Smith LLP
  • USA
  • May 13 2011

The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."


FDA issues advanced notice of new GLP rules for non-clinical studies
  • Reed Smith LLP
  • USA
  • January 13 2011

Following a workgroup's conclusion that non-clinical studies should be conducted under a good laboratory practices (GLPs) quality system approach, FDA has decided to modify the existing GLP regulations for non-clinical studies