• FDA is Soliciting Comments on Improving the Quality of ANDA Submissions
  • February 7, 2014 | Authors: Igor Gorlach; Paul T. Kim
  • Law Firm: Foley Hoag LLP - Washington Office
  • The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding common deficiencies in the following aspects: filing, chemistry, sterility, bioequivalence, fatal flaws, and drug master files. The new docket, FDA-2014-N-0032, will remain open until March 24, 2014, although FDA “welcomes comments at any time.”