Zdrowie i gospodarka · 02/09/1997

Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening the comment period on the draft guidance entitled ``Guidance for Industry: Computerized Systems Used in Clinical Trials'' until November 3, 1997. FDA published a notice of availability of the draft guidance in the Federal Register of June 18, 1997 (62 FR 33094). FDA is reopening the comment period in response to requests for additional time to review the agency's draft guidance on the use of computerized systems in clinical trials. DATES: Written comments may be submitted on the draft guidance document by November 3, 1997. General comments on agency guidance documents are welcomed at any time. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: James F. McCormack, Office of Enforcement (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0425. SUPPLEMENTARY INFORMATION: In the Federal Register of June 18, 1997, FDA announced the availability of a draft gu