The FDA released two documents today aimed at making the generic drug application and review process more efficient, the aim of its Drug Competition Action Plan.
The first, draft guidance for industry on good ANDA practices, addresses the common deficiencies that delay approval, many times due to missing non-study information. An ANDA goes through an average of four cycles before approval, which the guidance aims to reduce, saving time and money.
The second is guidance for FDA staffers which formalizes the generic review process and provides clarity and consistency to the function. One goal is to provide more detailed feedback to applicants on the specific actions needed to get a rejected ANDA approved aimed, again, at reducing the number of application cycles.
Commissioner Gottlieb is making things happen. The FDA took action on more applications in the last half of 2017 than any other six-month period in its history.