FDA Withdraws Part 11 Guide!

GMP News No. 287

14 February 2003

FDA Withdraws Part 11 Guide!

On 4 February, FDA withdrew the"Draft Guidance for Industry, 21 CFR Part 11; Electronic Records;Electronic Signatures, Electronic Copies of Electronic Records,"which had been published on 12 November 2002.
The reasons for this might lie with the fact that, due to the "CGMPInitiative" announced on 21 August 2002, the responsibility regarding21 CFR Part 11 has been transferred from the Office of Regulatory Affairs (ORA)to the Centerfor Drug Evaluation and Research (CDER) headed by Joe Famulare. Theindustry has made a great number of comments as well as objectionsconcerning the interpretation of Part 11 and the Draft Guidances.

Within the framework of the "CGMP Initiative", FDA nowintends to use the time to possibly publish a modified version of theGuide.

Please click herein order to read the FDA statement on this measure (Docket No. 00D-1540).

Dr Andreas Mangel


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