Preparation for ICH Meetings in Brussels, Belgium, Including on Implementation of the Common Technical Document; Notice of Public Meeting.    (31DEC01)
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International Conference on Harmonisation; Draft Guidance on Electronic Common Technical Document Specification; Availability.    (28NOV01)
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The Draft Guidance

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-ANDAs; Availability.    (16NOV01)
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The Draft Guidance

International Conference on Harmonisation; Guidance on M4 Common Technical Document; Availability.    (16OCT01)
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The Guidance M4: Organization of the CTD                                                                              M4E: The CTD-Efficacy                                                                                                                           M4Q The CTD-Quality                                                                                                                                    M4S: The CTD-Safety                                                                                                                             M4S: The CTD-Safety Appendices

Draft Guidance for Industry; Electronic Records; Electronic Signatures, Glossary of Terms; Availability; Correction.     (03OCT01)
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Preparation for ICH Meetings in Brussels, Belgium, Including Progress on Implementing of the Common Technical Document; Public Meeting; Cancellation.    (01OCT01)
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Draft Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation; Availability.     (24SEP01)
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The Draft Guidance                                                                                                                          The Draft Guidance html

OC 2001170.  Draft Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Availability.    (24SEP01)
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The Draft Guidance html version                                                                                                                 The Draft Guidance

Draft Guidances for Industry on Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format: General Considerations and for Food Additive and Color Additive Petitions; Availability.   (31JUL01)
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The Draft Guidance: General Considerations
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CDER 46.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format, Prescription Drug Advertising and Promotional Labeling; Availability.  (31JAN01)
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Draft Guidance

Electronic Filing of Drug Registration and Listing Information; Notice of Pilot Project Agency.  (09JAN01)
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