RAPS

FDA encourages industry to adopt modeling tools to ensure stable processes

An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling tools to ensure that manufacturing processes are ...
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 ...
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 ...
RAPS

FDA warning letters address CGMP, clinical study plan failures

Intas Pharmaceuticals was again in hot water with the US Food and Drug Administration (FDA) for a host of current good manufacturing practice (CGMP) violations, including manipulating particle counts ...