National Academies of Sciences%2c Engineering%2c and Medicine

Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease

This activity was supported by the Agricultural Research Service of the U.S. Department of Agriculture (Grant # 59-0204-5-001); Health Canada (Contract No. 4500358459); the National Cancer Institute, ...
JD Supra

FDA Announces Rare Disease Evidence Principles to Accelerate Treatments for Ultra-Rare Genetic Diseases

The U.S. Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) to allow for faster approval of treatments for ultra-rare genetic diseases. A product is eligible if it ...
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 ...