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Just a BE study for 505(b)(2) approval? Likely not!

I have addressed this topic before but from several recent discussions I thought it useful to repeat this here.

A number of companies hope to do just BE studies to obtain approval.  The proposed changes to the RLD are formulation, dosage form, IR to ER, etc. The sponsor believe or has designed the product to have the same bioavailability and dose as the RLD.  Some people have expressed the idea that the product can be approved on BE studies alone just like a 505j (generic).

Most often this logic is wrong.

To obtain NDA approval a sponsor must provide information in all sections of the NDA and this information must meet currentapproval standards. Many (most?) drugs approved even 5 years ago would not be approved today with the same information they used for approval. You need to know what the approval standards are today (and try to determine what they will be when your drug is going to be approved) and find as much public information as possible to meet those standards. The difference between what data is needed for approval and what data is publicly available is the development plan. Camargo’s value is that we are at the FDA several times per month and have a very good handle on the evolving approval standards. Our highly trained research staff comprised of specialty trained post-Ph.D. ‘s know where to find public information and how present it in a fashion that often can convince FDA to accept public data in lieu of sponsor’s studies.