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

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
Pharmaceutical Commerce

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
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 ...
TheStreet on MSN

The use of AI in the drug development process

Broadcast Retirement Network's Jeffrey Snyder discusses the use of Artificial Intelligence in the creation of new drug with Early-Stage Biotech Scientist Andrew R. Snyder, PhD.
The American Journal of Managed Care

How Patient Voices Shape Regulatory Drug Decisions: Eleanor Perfetto, PhD

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...
Business Wire

Thermo Fisher Scientific Showcases Enhanced Accelerator™ Drug Development Capabilities and OpenAI Strategic Collaboration at CPHI Frankfurt 2025

FRANKFURT, Germany--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, will showcase its latest flexible solutions to help boost efficiency and scale in ...