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eCTD Seminar
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   2050
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IND, NDA, BLA, Correspondences, Safety Reports; MAA, CTA, 510ks, other marketing apps… eCTD vs. hybrid esub; Format: PDF, XML, SAS, MSWord, JPG
Quality Control Principles in Recombinant Vaccine Production
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   1518
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The human papilloma virus (HPV); expression of HPV L1 in eukaryotic cells (e.g. S. cerevisiae) results in the formation of L1 VLPs, which,
The eCTD Module 5
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   853
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esub@cder.fda.gov . Guidance-Compliant eCTDs: Module 5 . Armando Oliva, M.D. Associate Director for Policy . Office of New Drugs. CDER / FDA . Company logo here
eCTD Quality/CMC Issues
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   328
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For print CTDs, don’t use attribute names where there is only a single attribute value e.g. S.2 Manufacturer (amoxicillin, ABC Inc)
eCTD Workshop
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   252
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Relative path and filename for the eCTD backbone file containing the modified file’s leaf element; Example file submitted in sequence number 0000 replaced
PPT- ISE/ISS Analyses Clarity in a CTD or eCTD – Clinical Reviewer . - Slideworld Medical Search Engines
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   182
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PPT- ISE/ISS Analyses: Clarity in a CTD or eCTD – Clinical Reviewer Perspective . Armando Oliva, M.D. Associate Director for Policy. Office of New Drugs
PPT- Update on Electronic Submissions Using eCTD Specifications . - Slideworld Medical Search Engines
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   113
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PPT- Data definition file for the SDTM, see CDISC; For the specification for providing the data definition files for other datasets, see Providing Regulatory Submissions
JPMA - View Article
Author: Anonymous
Institution

Powerpoint Presentation Downloads:   95
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CDER-Centric View; Customer -- Not in Office of ... online.wsj.com/article_print/SB114644463095840108.htm ... JPMA . CDC . Reference . Information Model. RIM . LAB . eCTD


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