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Re:It Costs $30 to Make a DIY EpiPen by rayiner on Wednesday September 21, 2016 @11:45PM (#12554168)
There are accelerated approval processes for precisely what you're describing. Section 505(b)(2), for example, allows an applicant to rely on studies conducted for a previously-approved drug with the same active ingredient. And of course the whole ANDA generic approval process.

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