OGD Will Hire Staff to Reduce ANDA Supplement Backlog

The FDA’s Office of Generic Drugs (OGD) plans to hire more staff this year to reduce its backlog of ANDA supplements. The new staff will work on supplements, original applications and related review work such as consults and citizen petitions, OGD Director Gary Buehler said. OGD also is waiting for a guidance to be posted that will decrease the number of submissions requiring a supplement, Buehler said.
Drug Industry Daily