1 research outputs found
A Primer on CBER’s Regulatory Review Structure and Process
- Author
- Center for Biologies EvaluationResearch CBER
- Complete ReviewIssuance of Action Letters.
- Designation of License Application Amendments as Major or Minor.
- Guidance for Industry.
- Guideline for Drug Master Files.
- Intercenter Agreement Between the Center for Biologics EvaluationResearchthe Center for DevicesRadiological Health.
- Intercenter Agreement Between the Center for Drug EvaluationResearchthe Center for Biologies EvaluationResearch.
- KC Zoon
- KC Zoon
- Procedure for the Classification of Resubmissions of an Application for a Product Covered by the Prescription Drug User Fee Act PDUFA.
- Suzanne M. Sensabaugh
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
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