FDA publishes draft guidance containing 24-month notice of eCTD mandate http://t.co/KpmJqP5LqB
Welcome to Sage Submissions
Sage Submissions is dedicated to helping you streamline the process for creating submissions for drug, biologic and medical devices. Sage Templates™, a MS Word-based tool, helps you create documents that support the global electronic Common Technical Document (eCTD) submission standard. The templates also support all FDA CDRH and Global Harmonization Task Force (GHTF) Summary Technical Documentation (STED) pre-submissions and submissions in Electronic Copy format.
Sage Templates are optimized to comply with global agency guidances and specifications for PDF files and for the content and granularity of electronic regulatory submissions. Entering required content is easy with the Sage Toolbars, which contain all of the MS Word functions you need to structure your documents and convert them to PDF. Sage Templates Self-Paced Training and Style Guide round out the software product offerings from Sage Submissions.
Sage Submissions also provides MS Word and Adobe Acrobat training, document remediation, PDF conversion, submission publishing and eCTD submission validation services.
FDASIA 2012 Impact on Electronic Submission Requirements of Drug, Biologic, and Device Companies
The FDA Innovation and Safety Act (FDASIA) of 2012 became effective 1 October 2012. The act mandates that applications to CDER, CBER, and CDRH be submitted electronically. While the mandates will take 24 to 36 months to become effective, sponsors will be required to pay user fees under PDUFA V, MDUFA III, and GDUFA beginning October 1 for new submissions, and to clear up the backlog of unapproved ANDAs and unreviewed DMFs. This means that sponsors will pay the user fees and receive none of the benefit of the review timelines contained in FDASIA unless their applications use eCTD for drugs and biologics, and Electronic Copy for devices. This applies to sponsors submitting Drug Master File Type II (DMF-II) for drug product, ANDAs, NDAs and BLAs, and device companies submitting all forms of pre-submissions and submissions to CDRH.