2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: Sept 24th - Sept ...

Market opportunities include gaining a comprehensive understanding of FDA procedures for US pharmaceutical submissions, critical for navigating the largest global market. This course provides deep ...
Regulatory Affairs Professionals Society

Pharma industry wants clarity on plausible mechanism framework

The US pharmaceutical industry expressed support for the US Food and Drug Administration’s (FDA) proposed framework for ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
C&EN

FDA’s new drug approvals dipped in 2025

Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...