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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

Origin/Publisher:

FDA

Content:
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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