FDA Will Allow ANDA Corrections … Until 10 Minor Deficiencies Found
This article was originally published in The Pink Sheet Daily
GDUFA refuse-to-receive draft guidance says that agency will allow sponsors to make a few small fixes to their applications, but FDA won’t accept any ANDAs that have big problems.
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Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.
The U.S. FDA wants to know whether its 180-day generic exclusivity process should be revealed up front; the question will be one of many on ANDA reviews to be considered at a September public hearing.
In a win-win for agency and industry, generic applications submitted before deadline for new stability requirements still will be judged by old standards, even if the ANDAs are amended or resubmitted.