FDA has put on the table its expectations for complying with the Generic Drug User Fee Amendments (GDUFA) – including two draft guidances clarifying the payment of fees and registration of manufacturing facilities – and is asking for quick industry feedback as the beginning of the implementation process for GDUFA draws near.
The more extensive of the two GDUFA implementation guidances includes coverage of: ● fees ● self-identification of facilities, sites and organizations that manufacture, package, repackage or test generic drugs, and ● review of generic drug submissions. The 25-page draft contains 64 questions and answers.
A second draft guidance provides more detail on the self-identification issue. It addresses which facilities are required to self-identify, the process for doing so, and the penalty for failure to comply. The comment period on both documents ends October 26.
The two draft guidances were published in the Federal Register on August 22 along with two other notices providing: ● instructions for withdrawing existing abbreviated new drug applications (ANDAs), and ● an announcement of a public meeting to solicit industry feedback on the agency’s implementation proposals.
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