The reauthorization of the Generic Drug User Fee Act GDUFA, which takes effect on October 1, 2017 and commences GDUFA II, has many significant changes relative to goal dates for ANDAs, amendments to ANDAs, and amendments to prior approval supplements. The system for classifying the goal dates has been simplified from a tiered system under GDUFA I to a standard and priority review system under the new GDUFA iteration.
OGD has released a new Q&A document relative to refuse-to-receive issues. I must be quite frank, there were some questions and their answers of which I was not aware. Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing.
After years of internal FDA debate, the FDA issued a guidance yesterday which was designed to assist an ANDA applicant in “determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food,
Don’t need to get out your GPS because MaPP 5220.3 will help you understand how OGD plans to navigate the filing review to communicate major and minor deficiencies to the applicant in an information request (IR). If the minor deficiencies can be resolved within a 7-day period, then your ANDA has the chance to be received on the original submission date.