Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
16 January 2018 - Today the U.S. Government Accountability Office published a report titled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.”
In preparing the report, the Government Accountability Office (GAO) studied a number of issues related to the FDA’s review and approval of “non-biological complex drugs.” The report contained a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products.
We agree with GAO’s recommendation and the FDA is actively working to accomplish this goal through new policies that are already underway.
