FDA released new version of electronic common technical documents (eCTD) Module 1 documents including specification guidance, DTD, style sheets and New Attributes list.
These documents in draft (only for review not for implementation) FDA is working with Sponsors (Pharma/Biotech and Software vendors) Soon they will release the final guidance with some changes.
As per the new draft The Comprehensive Table of Contents Headings and Hierarchy document version 2.0 there are many additions and corrections of sections in module 1.
As per the new the eCTD Backbone Files Specification for Module 1 (Version 2.0), there are many changes in Module 1 specification including new attributes called submission sub-type, submission description, application contact, submission-id, submission unit id etc….
Apart from above mentioned documents FDA has released draft Regional DTD, Style Sheet, Module 1 new attributes list information.
For more information about the documents please navigate to the following FDA webpage.
(Kindly note these documents are only for review not for implementation).
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm
Dear All,
ReplyDeleteWe wont find the FDA M1 draft guidance in the above mentioned location.FDA will officially distribute the M1 documents soon. We will wait and watch the upcoming Federal Register Notice.
Kind Regards
Shakul
We can find the FDA M1 Draft Guidance in the following location.
ReplyDeletehttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm