Today in a prepublication Federal Register notice, (due to be published tomorrow), the FDA announced the addition of 29 new and 19 revised product specific guidance (PSG) documents. The Agency acknowledges that, “as part of FDA’s commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.” Many of the newly issued guidances reflect this category of product, helping to assure that new generic products can get to market more quickly and efficiently.
The one thing that continues to reduce the efficiency of this process and causes industry great angst is the frequent revisions of PSGs. Many times, there are minor changes, but there are certain times that the revised guidances require firms to repeat bioequivalence testing (which is expensive and time-consuming), thus delaying filing or approvals. These PSG revisions can occur prior to filing, after the ANDA has been received, and sometimes even after ANDA approval. The revisions are chalked up as part of the FDA learning process, as new and usually unforeseen issues arise, either through filed citizen petitions or additional information the Agency becomes aware of during or after the application approval process.