FDA Invites Comment On Continuous Manufacturing

27 Feb 2019

Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.

ContinuousProduction — The FDA Has Issued Draft Guidance On Continuous Manufacturing • Source: Shutterstock

Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration (FDA). With a 90-day period for interested parties to submit comments and suggestions, the document covers small-molecule oral solid-dosage forms regulated by the center for drug evaluation and research (CDER).

Describing “key quality considerations”, the guidance gives recommendations for how abbreviated new drug application (ANDA) and new drug application (NDA)...