How Long Does Fda Have to Review Nda
Compiling and submitting an NDA is a complicated and intensive action. In one case you have submitted your application to FDA, you may be curious about what can you expect to hear and when. Below are some of the common questions nosotros receive from sponsors about what to expect during the NDA review process.
When will I know that my NDA has been accepted for filing?
You volition know within 60 days of submitting your NDA whether it has been accustomed for filing (or conversely, if FDA refuses to file your application due to lack of information or studies). If your application is accepted for filing (60 days after submission), then you lot will receive an FDA 74-day letter, which contains a planned NDA review timeline that varies based on several factors such as whether other similar drugs already be or whether your drug treats an unmet medical need.
The FDA 74-Twenty-four hours letter also confirms your action date, confirms standard versus priority review, and identifies any preliminary deficiencies in your application. Sponsors must deed chop-chop to resolve the deficiencies noted in the FDA 74-mean solar day letter during the NDA review process, so it'due south appropriate to seek outside assistance from an experienced compliance consultant.
How many data requests can nosotros expect to receive during the NDA review process?
The answer is that information technology varies, and in that location actually is no predicting how eventful your review volition exist. Throughout the course of the Agency's review, there are likely to exist issues that come upward, but the number and significance of these requests volition vary from application to application. Hopefully you took the time to ensure that all of the components of your NDA were accurate and complete, and y'all reviewed any previous correspondence with the Agency to brand sure that all problems were addressed. Nevertheless, FDA may request clarification on where information resides in your NDA, clarification on data you already provided, or they may request additional analyses. Y'all should also be prepared for an inspection of the facility or facilities where the drug will be manufactured, which may outcome in additional requests.
Regardless of how many information requests you lot receive during the NDA review process, information technology is important that you brand sure you sympathise what FDA is request for and that yous respond with information that is clear, comprehensive and transparent. This volition assistance the reviewers understand your response and minimize the need for additional follow-upward questions or requests. It is the sponsor'southward responsibility to respond to these requests every bit before long as possible, as timely and consummate responses help ensure that you don't inadvertently push button out your activeness date.
When does characterization negotiation occur during the NDA review process?
This very disquisitional step takes identify at the very end of the review, in many cases in the last ii weeks. Tensions frequently run high during this period, since many parties have an involvement in the final wording of the characterization. Yous should have adult potent, information-driven statements nigh your production prior to submission, but y'all need to be prepared to defend those statements at present. Because timing and responsiveness is critical at this stage, all of import members of your team should exist available to review versions of labels and participate in calls on very brusque find.
NDA submission and review timeline
The NDA review process is long and complex, so brand certain yous're aware of what to expect during each stride and so you accept plenty of time to gear up in advance. The FDA has provided the following NDA timeline to help visualize the entire process.
(Source: FDA )
Whether you lot are compiling an NDA for submission or responding to requests during FDA review, it is of import to recollect that an NDA is the most important and most complex series of documents that you will demand to assemble during your product's lifecycle. An accurate and consummate NDA is critical to ensuring a streamlined review and maximizing the likelihood of product approval.
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Source: https://www.propharmagroup.com/blog/nda-review-fda-submission/