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 ...
Nature

Continuous Casting Process and Defect Management in Steel Production

Continuous casting remains a critical process in modern steel production, whereby molten steel is poured into a mould and solidified into semi-finished forms such as blooms, billets or slabs. This ...
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 ...
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 ...