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FDA Guidance for Industry: Submission of Documentation in applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes



This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other post-marketing report

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