Revised GDUFA Guidance Clarifies Packager & Fatal Flaw Definitions

Companies that package an approved ANDA product for the first time are classified as a packager subject to GDUFA’s facility fees, the FDA says in newly revised GDUFA question-and-answer guidance. The agency’s update to the August 2012 document follows the Sept. 4 public shaming of facilities that failed to submit their annual facility fee required under the Generic Drug User Fee Act.
Washington Drug Letter