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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

AUGUST 22, 2021

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC.

Containment

Containment Bioavailability Cosmetics Packaging

Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

FDA Law Blog

JANUARY 23, 2023

More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

Trials

Trials Clinical Trials Clinical Trials Drugs

Clinical Research Informer

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

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