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Results: 11-20 of 82

Draft guidance on continuing IRB review after clinical investigation approval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A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the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


GAO report on drug safety oversight
  • Reed Smith LLP
  • USA
  • December 21 2009

A recent GAO report points to improvement in FDA’s postmarket drug safety oversight, but the agency expresses concern over continued gaps in particular areas


FDA public meeting and comment request on incorporation of new science into CDRH regulatory decision making (Feb. 9, 2010)
  • Reed Smith LLP
  • USA
  • December 21 2009

FDA is holding a public meeting on February 9, 2010 to discuss measures for incorporating new science (i.e., novel technologies or novel uses of existing technologies, evolving information and knowledge, or new methods to support decision making) into the FDA Center for Devices and Radiological Health decision-making processes


FDA issues warning letters to web site operators
  • Reed Smith LLP
  • USA
  • December 4 2009

On November 19, 2009, FDA completed a coordinated and collaborative international effort intended to curb illegal actions involving medical products sold via the internet


FDA enters agreement to support WHO with counterfeit drug efforts
  • Reed Smith LLP
  • Global, USA
  • October 15 2010

The Food and Drug Administration (FDA) has entered into a collaborative agreement with the World Health Organization (WHO) in an effort to support the development of a global surveillance and monitoring system for combating counterfeit medicines and breaches in the supply chain


FDA seeks comment on 5 year strategic priority plan
  • Reed Smith LLP
  • USA
  • October 15 2010

FDA seeks comments on the agency's draft document, "Strategic Priorities FY 2011-2015."


FDA final guidance documents on writing requests for product designation
  • Reed Smith LLP
  • USA
  • April 28 2011

The FDA has released final "Guidance for Industry on How to Write a Request for Designation."


FDA draft guidance on electronic source documents in clinical trials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FDA has published a draft guidance entitled "Electronic Source Documentation in Clinical Investigations."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 public workshop on Sentinel Initiative (Jan. 12)
  • Reed Smith LLP
  • USA
  • December 14 2010

FDA is holding its third annual public workshop on the Sentinel Initiative on January 12, 2011


FDA seeks comments on clinical benefit information in professional labeling, direct-to-consumer print advertisements
  • Reed Smith LLP
  • USA
  • December 15 2010

FDA has announced plans to conduct a study entitled "Clinical Benefit Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs."