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Guidance for Industry
M2: eCTD Specification
Questions & Answers
and Change Requests
Companion Document:
Current Q&As and Change Requests
[posted 7/10/2008]
(See Document Change History for version and date.)
| This guidance represents the Food and Drug
Administration's (FDA's) current thinking on this topic. It
does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. You can use an
alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If
you want to discuss an alternative approach, contact the FDA
staff responsible for implementing this guidance. If you
cannot identify the appropriate FDA staff, call the
appropriate number listed on the title page of this guidance. |
U.S. Department of Health and Human
Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
ICH
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Date created: March 14, 2005; updated 1/6/2006 |
