바이오인

 Guidance for Industry 

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current  thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of  the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 

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이 자료는 KASBP(Korean American Society in Biotech and Pharmaceuticals) : 재미한인 바이오텍-제약산업 과학자협회 문영춘(현 KASBP 회장) 박사님께서 모니터링하여 보내주신 자료입니다.