FDA Experience with eCTD Gary M Gensinger Director, Regulatory Review Support Staff Office of Business Process Support Center for Drug Evaluation and Research

eCTD Submissions (as of September 18, 2007) Application Count Submissions IND 462 7,694 NDA 247 3,653 ANDA 295 981 BLA 48 1,669 DMF 101 132 FDA Internal 154 243 Total 1,310 14,372

Who’s Submitting 184 Unique Sponsors…Maybe Much Inconsistency Acme Group Limited Acme Group Limited d/b/a Acme Acme Group Limited dba Acme Acme Group Limited, dba Acme AcmePharmaceuticals AcmePharmaceuticals, S. A. d/b/a Acme AcmePharmaceuticals, S.A. d/b/a Acme AcmePharmaceuticals, S.A. dba Acme

Withdrawal of Guidance Waiver policy awaiting posting Blanket exceptions include Mid-cycle cutovers to new format Relaxation of once eCTD always eCTD for paper filers who submit Labeling Carcinogenicity datasets to INDs Will be found in Electronic Submission Docket http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s0251.htm

eCTD Pilot Process No-Risk way to validate your eCTD understanding Continuing to receive pilot submissions Pilot submission evaluated for technical compliance only unless directed otherwise Accepting all submission types, e.g., IND, NDA, Amendments, Master Files, Annual Reports… Generally not required if using experienced submission publisher

Electronic Submission Gateway Critical to Improving Efficiency Gets your material to the reviewer in an expedited manner Introduces automation into FDA Processes Use of electronically fillable forms key Move validation into the forefront

Validation FDA finalizing its eCTD Validation Specification Not currently being applied ESG Requirements re: file/folder naming Spaces and special characters not allowed Consistency Checking application-type="nda“ but 1571 form submitted <application-number>919297</application-number> but form says 567981

Gary Gensinger gary.gensinger@fda.hhs.gov 301.796.0589