I get a lot of requests to assure people that their project is, or is not, a 505(b)(2). A few questions about whether it is an OTC candidate. The question about whether the proposed drug is a 505(b)(1) or 505 (b)(2) is readily answered by the question, “Is any data essential for approval being obtained from a public source?” If the answer is yes, then it is a 505(b)(2). Is it an OTC? The FDA has a decision tree (thumbnail below) that might be helpful. This same chart does a nice job differentiating a 505(b)(2) from an ANDA (505(j)).
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