Four Reasons Drugs are Expensive – Of Which Two are False
From Matthew Harper at Forbes.
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Source: Forbes
Thai eCTD FAQ - In 2017 eCTD submission will be mandate for all submission
eCTD Submission will be mandate for New Chemical Entity, New Drug, New Biological, Biological and optional for Generic and New Generic in 2016. In 2017 eCTD submission will be mandate for all submission.
Thai eCTD FAQ- Read more...
Source: FDA
eCTD Technical Conformance Guide
FDA has published a Technical Specification Document, eCTD TECHNICAL CONFORMANCE GUIDE on its eCTD Web Page (added on 10/05/2015). This is the Initial Version and supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance).
This eCTD Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
This Guide should be considered a companion document to the following:
Guidance to Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
FDA eCTD Web page
FDA Data Standards Catalog
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Source: FDA
