GDUFA was enacted into law in July 2012, as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).
GDUFA is based on an agreement between FDA and the human generic drug industry, codified by Congress, to accelerate the delivery of high-quality, lower-cost human generic drugs. FDASIA authorizes GDUFA for a 5-year period from October 1, 2012, through September 30, 2017.
In the report, FDA published that it has met all GDUFA program commitments for Fiscal Year 2013:
- FDA received a total of 992 original ANDA Applications.
- FDA made significant progress towards reducing the GDUFA backlog. 30% of ANDAs and 40 % of PASs pending since October 1, 2012, received a first action in FY 2013.
In 2013, Asphalion has supported companies with various ANDA and DMF applications in eCTD format.
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