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Article: FDA withdraws electronic records guidance. (Breaking News).
- Article from:
- Biomedical Market Newsletter
- Article date:
- March 31, 2003
CopyrightCOPYRIGHT 2003 Biomedical Market Newsletter, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Draft guidance for industry on "Part 11, Electronic Records, Electronic Signatures--Scope & Application;" availability of draft guidance & withdrawal of draft Part 11 guidance documents & a Compliance Policy Guide.
[Federal Register: Feb. 25, 2003; Vol. 68, No. 37; pp. 8775-8776; Docket Nos. 03D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542 & 00D-1539].
ACTION: Notice; availability; withdrawal.
SUMMARY: The FDA is announcing the availability of a draft guidance for industry entitled "Part 11, Electronic Records; Electronic Signatures--Scope and Application." This draft guidance explains FDA's current thinking regarding the requirements and ...
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