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Results: 11-20 of 82

FDA to post new on-line information regarding safety monitoring issues for recently-approved drugs and biologics
  • Reed Smith LLP
  • USA
  • June 18 2010

FDA announced a new initiative, required under the Food and Drug Administration Amendments Act of 2007, to post summaries of FDA safety analyses and the agency's plan to address them on the FDA website


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 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 seeks comment on transparency proposals
  • Reed Smith LLP
  • USA
  • May 25 2010

FDA is rolling out phase II of the FDA's Transparency Initiative with the issuance of 21 draft proposals intended to expand disclosure of information while maintaining confidentiality of trade secrets and individually identifiable patient information


FDA and NIH launch safety reporting website
  • Reed Smith LLP
  • USA
  • May 25 2010

The FDA and the National Institutes of Health (NIH) have launched a website, called the Safety Reporting Portal (SRP), intended for the reporting of certain pre- and post-market safety data


FDA guidance on medical device voluntary audit report submission program
  • Reed Smith LLP
  • USA
  • May 25 2010

FDA has issued draft guidance on the implementation of Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA


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