Ainnocence and Phase Advance Enter Industry-First AI Collab to Reduce Drug Development Timeline and Clinical Trial Risk

The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
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 ...
C&EN

How will FDA changes reshape drug approval in 2025 and beyond?

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...
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 ...
Medscape

FDA Aims to Streamline Biosimilar Drug Development

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
Nature

The impact of accelerated drug marketing registration procedures on the review and approval of new drugs in China

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...
Los Angeles Times

Letters to the Editor: What makes drug research so expensive, even before the FDA approval process?

This is read by an automated voice. Please report any issues or inconsistencies here. A rare-disease patient questions what drives research costs behind $41,000-per-month medication, even before FDA ...