Regulatory Affairs Professionals Society

FDA oncology draft guidance aims to reduce animal testing

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...
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 ...
Regulatory Affairs Professionals Society

FDA finalizes two guidances for industry on establishing bioequivalence

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...
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 ...
News Medical

The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
Forbes

Reclaiming America’s Drug Innovation Edge

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. We are on a bureaucratic trajectory where American leadership in ...
The American Journal of Managed Care

FDA Q&A: Addressing Biosimilar Safety, AI in Drug Development, and Supply Chain Challenges

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...
JD Supra

FDA Makes Moves to Modernize Drug Development, Clinical Trial Paradigm

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” In conjunction with a ...
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% ...
Business Wire

Drug Farm Announces FDA Acceptance of DF-003 into Rare Disease Evidence Principles Process for ROSAH Syndrome

ALBANY, N.Y. & SHANGHAI--(BUSINESS WIRE)--Drug Farm today announced that the U.S. Food and Drug Administration (U.S. Food and Drug Administration, FDA) has accepted DF-003, the company’s ...