Government Regulations and Their Effect on the Drug Sector

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...
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’s Rare Disease Evidence Principles Process Provides Guidance for Applications Supported by a Single Pivotal Trial

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
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 ...
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 ...
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 ...
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% ...
Hosted on MSN

FDA Announces Groundbreaking Shift: Replacing Animal Testing With Advanced Human-Relevant Methods For Drug Development

In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a new initiative to significantly reduce, refine, and replace animal testing ...
National Academies of Sciences%2c Engineering%2c and Medicine

To Increase Pace and Volume of Drug Approvals for Rare Diseases, Report Recommends FDA Enhance Information Sharing, Improve Collaboration

The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and world. Our ...