It is important to note that these draft Guidances apply ONLY to ANDAs or Prior Approval Supplements FILED AFTER September 30, 2014. These will be the first ANDAs and PAS subject to GDUFA FDA Performance Goals.
Because FDA has to meet certain timelines for ANDAs and PAS filed after this date, the goals have to take into account amendments and deficiencies since these actions obviously affect FDA's ability to meet the timelines. The design of GDUFA is intended to strongly encourage sponsors to submit high quality, complete ANDAs and PASs and so "punishes" the need to amend or get deficiencies, the more significant the deficiencies the stronger the extended review time punishment. These draft Guidances detail the review timing changes that result from post filing deficiencies or amendments.
The first draft Guidance addresses the issue of amendments and deficiencies for original ANDAs. This is a complex topic and the description of the "tier" system in the GDUFA Commitment Letter is difficult to follow without a lot of time and effort. In addition, while setting conditions for deficiencies, it does not indicate what will be considered a major deficiency, a minor deficiency or an "easily correctable" deficiency. The draft Guidance gives examples of these in the Appendices which is very helpful. Note however that the definition of a major amendment has expanded considerably. Pre-GDUFA a major deficiency was anything that required the submission of new exhibit batch(es) or a new bioequivalence or clinical study. The examples of major deficiencies given in the draft Guidance number 35, and this is not an exhaustive list. Overall this is a very helpful draft Guidance.
The second draft Guidance concerns filing of PASs under GDUFA's FDA performance goals. This draft Guidance addresses Prior Approval Supplements, which require user fees under GDUFA and go through a similar process to new ANDAs in terms of filing and any amendments and deficiencies are also subject to a "tier" system. This is all explained in the draft Guidance and is quite clear. The issue of whether a PAS needs an inspection is a significant issue for PAS review timing and some situations are laid out in the draft Guidance to explain that inspectional requirements may not always be apparent at the time of supplement filing. In addition situations that could generate multiple PAS filings are covered.
Both these draft Guidances offer a lot of clarification of the performance requirements laid out in the Commitment Letter. They are each accompanied by a slide presentation which explains the Guidances and by a "webinar" which also explains the material in the Guidances ( Here ). The slide presentations are very well written and presented and add a lot to the understanding of these Guidances. It is interesting to note that both slide presentations were written by OGD staff members who are JDs. Perhaps this an indication of what the future holds in the GDUFA world!
