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Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps

 
• By Bowman Cox

Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.

Ampoules
how to be sure nothing bad will leach into product • Source: Alamy

In a development that could prevent some US Food and Drug Administration approval delays, a group of industry, regulatory and academic experts recently won agreement across agency review divisions on a consistent, streamlined approach to determining whether unsafe levels of chemicals might leach into parenteral drugs from their containers.

The Product Quality Research Institute is a collaboration of the FDA, industry and academia that since 1996 has worked to put chemistry, manufacturing and

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