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FDA Suggests Preoperational Review Meetings Before Submitting NDAs For Continuous Manufacturing

 
• By Joanne S. Eglovitch

FDA suggests early site visits before submitting NDAs and supplements for continuous manufacturing to smooth over rough patches before pre-approval inspections. Agency also shares some insights on what inspectors will be looking for during PAIs of continuous manufacturing facilities.

An FDA official recommended that the pharmaceutical industry request “preoperational review” meetings prior to submitting applications for drugs produced on a continuous manufacturing line. That way FDA can convey expectations early on and the industry can avoid costly design or construction problems.

FDA officials described the agency’s evolving expectations on continuous manufacturing at an April 20-21 International Society for Pharmaceutical Engineering meeting...

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