What’s in Module 3 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 3 of the CTD contains the Quality data, which is the detailed information on the chemistry, manufacturing process, and control strategy for both the drug...
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The 21st Century Cures Act Changed What is Considered a Device
Check out new guidance and webinar for details As I’ve previously mentioned, section 3060 of the 21st Century Cures Act specifically exempts certain types of software functions from FDA regulatory oversight as medical devices. CDRH has issued the final level 1...
Electronic Regulatory Submissions Part 8
What’s in Module 2 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 2 of the CTD contains summaries of information presented in detail in modules 3-5. It starts with a one-page introduction that covers the pharmacologic class,...
Cybersecurity for Medical Devices Part 1
IMDRF Draft Guidance is Available for Comment until December 2, 2019 The International Medical Device Regulators Forum released a draft guidance on cybersecurity in early October, and it will be available for public comment until December 2nd. The guidance reinforces...
Electronic Regulatory Submissions Part 7
Module 1: Regional Administrative Information and Prescribing Information Because the eCTD is based on the ICH CTD, my next few posts will cover the content in each of the specific CTD modules. Module 1 contains the region-specific information and is the only module...
Electronic Regulatory Submissions Part 6
The History of the CTD and eCTD (Note: This post is part of a multi-part series on the CTD this fall) The history of the ICH eCTD is shown in this ICH slide deck from 2011, a program overview presented by the Rapporteur (that’s the person appointed to report the...
The Drug Development Tool Qualification Programs
The FDA has established 3 programs for qualification of Drug Development Tools (DDT): Animal Models, Clinical Outcome Assessments, and Biomarkers A qualified DDT is publicly available to be used in any drug development program for its qualified context of use, and...
Electronic Regulatory Submissions Part 5
The Common Technical Document Provides a Structure for Submission (Note: This post is part of a multi-part series on the CTD this fall) Before it became electronic, the common technical document (or CTD) was proposed by an ICH steering committee as a means to...