FDA chief warns US is losing ground to China in early drug development, calls for faster ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
Applied Clinical Trials Online

FDA Removes Two Study Requirement for New Drug Approval Process: Report

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
BioPharma Dive

FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.
Medscape

FDA Changes Drug Trial Guidance: Experts Take Sides

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Pharmaceutical Technology on MSN

FDA’s commissioner vouchers prompt questions about award process

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...
WRAL

FDA awards $50 million to Triangle universities for joint work on drug development process ...

The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of ...
The Scientist

Understanding the Drug Development Process

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...