美国FDA ANDA 申报生物等效相关法规，兼应助

潇湘子

求申报ANDA 相关法规505(j)，最好有FDA网站链接  @kodaliu @Anne @紫苏叶
https://www.ouryao.com/forum.php?mod=viewthread&tid=80425&fromuid=19478

3. What is a 505(b)(2) application?

A 505(b)(2) application is one described under section 505(b)(2) of the act as an application for which one or more of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)). This provision expressly permits FDA to rely for approval of an NDA, on data not developed by the applicant such as published literature or the agency’s finding of safety and effectiveness of a previously approved drug.

505(b)(2) applications are submitted under section 505(b)(1) of the act and are therefore subject to the same statutory provisions that govern 505(b)(1) applications that require among other things, "full reports" of safety and effectiveness.

4. What is an abbreviated new drug application (505)(j)?

An abbreviated new drug application is described under section 505(j) of the Act as an application that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things to a previously approved application (the reference listed drug (RLD). ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD. In general, the bioequivalence determination allows the ANDA to rely on the agency’s finding of safety and efficacy for the RLD.

5. What is a full new drug application 505(b)(1)?

A 505(b)(1) application is described by section 505(b)(1) of the act as an application that contains full reports of investigations of safety and effectiveness, in addition to other information. The data in the application is either owned by the applicant or is data for which the applicant has obtained a right of reference.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm



ANDA (An abbreviated NDA) 505(j) An application for a proposed drug that is identical to a reference listed drug and must demonstrate its bioequivalence”
，实际就是美国联邦法典CFR 21里面的"21CFR314.101(d)(9)"
地址见：http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG22

  

潇湘子

另外，可以上美国联邦法典在线网站查询相关条款：
《联邦行政法典》在线  (CFR  on  Line)  http：//www.gpoaccess.gov/cfr/index.html　

Anne

潇湘子真是牛呀，佩服，佩服！

紫苏叶

@kodaliu   解决了你的请求了吗？`{:soso_e179:}潇湘子是强人

kodaliu

谢谢了，嘻嘻，有收获哈哈

小小虫木

谢谢楼主分享

深海鱼

谢谢分享！