FDA Invites Comment On Continuous Manufacturing
Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.
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A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at a recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.
Commissioner Scott Gottlieb and center for drug evaluation and research (CDER) director Janet Woodcock have insisted that the FDA is maintaining “strong oversight of generic drug quality issues domestically and abroad”.