The Food and Drug Administration (FDA) released 408 automatic renewal (AR) drug applications as of May 31, 2021, according to the Anti-Red Tape Authority (ARTA).
The fasttracked AR of these applications served as a reply to the show-cause order issued by ARTA to the FDA Center for Drug Regulation and Research (CDRR) for its alleged inaction on the applications that date back as far as 2016.
ARTA said in a statement four applications are pending because two were not submitted by the client while the other two were re-routed to other centers or units.
One of those caught up in the CDRR is the application of Ambica International Corp. that was received by the drug center on February 2017 but was only approved on May 28, 2021– four years from its date of application. Ambica is the distributor of COVID-19 vaccine Covavax.
ARTA said it is evaluating FDA CDRR’s reply before recommending an appropriate action.
