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Blog & Resources Camargo Blog March 26th, 2010

505(b)(2) Approvals

I have seen various postings and articles on the number of 505(b)(2) approvals. The numbers do not always agree. Why don’t they agree? Many people look only at the approval letter. The FDA will always indicate that the NDA was submitted as a 505(b). But the Agency will not always indicate whether it is under (b)(1) or (b)(2). Since some approval letters state 505(b)(2), some people may assume that if it is not designated (b)(2) then it must be (b)(1). That would be wrong. Some Divisions do not state the sub-paragraph at all.

To find the sub-paragraph, one must look at the administrative documents. There are various documents that contain a check box for (b)(1) or (b)(2). I wish I this was consistent and the Agency always checked the boxes, but in many cases, the boxes are left unchecked. I guess only those working in 505(b)(2) really care about this designation.

I work hard at getting the approvals right. If you find a mistake, please let me know.



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