This guidance provides details on the expected content to be filed related to clinical sites, subjects and their data that will be used to support clinical site inspections.
"This guidance describes the electronic submission of certain data and information in standardized formats and applies to electronic submissions of data and information from all major (i.e., pivotal) studies used to support safety and efficacy claims in new drug applications (NDAs), biologics license applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and supplements containing new clinical study reports. It also applies when these data and information are submitted in certain investigational new drug applications (INDs) in advance of a planned NDA, BLA, or supplement submission."
- Details are provided on a number of topics including:
- · Listing of all clinical sites
- · Listing of all entities the Sponsor has contracted portions of the clinical studies
- · Protocol, Protocol Amendments, and Annotated Case Report Form(s)
- · By subject detailed data listings
These are expected along with a "summary-level clinical site dataset contains data from all major (i.e., pivotal) studies used to support safety and efficacy in the application, including studies with different treatment indications".
The final guidance is available here: https://www.fda.gov/media/85056/download
#fda #BIMO #CDERSubmission #ClinicalSiteData
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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