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January 10, 2007
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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. full news item
March 24, 2006
June 1, 2005
March 28, 2005
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FDA
publishes a draft guidance for industry intended to help
sponsors, institutions, IRBs, and clinical investigators
involved in multicenter clinical research meet FDA
requirements by facilitating the use of a centralized IRB
review process.
Guidance for Industry:
Using a Centralized IRB Review Process in Multicenter
Clinical Trials [HTML]
or [Word]
or [PDF]
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availability of a draft guidance for industry entitled "Computerized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 This draft guidance, when finalized, will supersede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 website soon.
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