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FDA Announces the Availability of Two Guidances Related to Clinical Investigations

January 10, 2007

  • FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products.  As a precaution, the Food and Drug Administration (FDA) is notifying certain pharmaceutical companies to recommend that they reevaluate pharmacokinetic studies that were conducted for them by MDS Pharma Services (MDS Pharma) at its St. Laurent (Montreal) and Blainville, Quebec, Canada sites from 2000 through 2004. MDS Pharma is a contract company that performs these pharmacokinetic testing services for a number of pharmaceutical companies.

March 24, 2006

June 1, 2005

March 28, 2005

September 30, 2004

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Computerized Systems Used in Clinical Trials". This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to the FDA. This draft guidance, when finalized, will supersede the guidance of the same name issued in April 1999. Written and electronic comments may be submitted to the Division of Dockets Management (Docket 2004N-0440).

July 29, 2004

  • FDA is proposing to require institutional review boards (IRBs) to register at a site maintained by the Department of Health and Human Services (HHS). Federal Register notice, July 6, 2004.
  • DSI is developing a web-based complaint form for complaints pertaining to FDA regulated research. For more details, please see the Federal Register notice, June 30, 2003.

July 21, 2004

  • Dr. Lester M. Crawford, Acting FDA Commissioner, announced new standards for submission of human and animal study data in electronic format on July 21, 2004. FDA has included this standard in a new guidance. As the guidance states, these specifications are for submitting animal and human study data in electronic format. The guidance also says that the implementation guide for using the model for animal toxicology data is being developed by the Standard for Exchange of Nonclinical Data (SEND) Consortium and will be available on the CDISC web site soon.


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