FDA Law Blog
JANUARY 23, 2023
Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.
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. 2.3.2: Repeat-Dose Toxicity. Code 1734.
Drug Discovery World
FEBRUARY 2, 2023
ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. The Modernization Act 2.0
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