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

Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports.

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

Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act). This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol.

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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