FDA Will Allow ANDA Corrections … Until 10 Minor Deficiencies Found
GDUFA refuse-to-receive draft guidance says that agency will allow sponsors to make a few small fixes to their applications, but FDA won’t accept any ANDAs that have big problems.
GDUFA refuse-to-receive draft guidance says that agency will allow sponsors to make a few small fixes to their applications, but FDA won’t accept any ANDAs that have big problems.