Good ANDA Submission and Assessment Practices and Software Support – FDA Generic Drug Forum 2018

for those who know me I will never ever bet anyone from going to once quickly so I'm going to try to get through this quickly so everyone can eat and stop those grumbling stomachs okay so today I'm going to be talking about two documents the first is the good andis Submission practices draft guidance for industry and then the second is the good and assessment practices manual of policies and procedures also known as a map so as back as background the drug competition action plan was announced in 2017 this is a multi-step plan to increase market competition and facilitate entry of low-cost alternatives into the market one component of decap is to streamline and a submission and and review to achieve this goal we release these to talk documents that I'm going to talk about today so the guidance in the map they contain different information and they are in their targeted towards different audiences but we think that both of them serve as process improvements that are going to build upon the success of the good Aoife program that Cooke and Ted talked about earlier today so the guidance is geared towards applicants to help you avoid common deficiencies that can lead to a delay in ananda review or into approval the map in contrast is targeted towards OGD and opq and it improves the efficiency and effectiveness of our assessment so the good and a submission practices guidance it describes common recurring deficiencies that can delete lead to a delay ananda approval these are the things that we see over and over again that results in deficiencies the guidance is limited to deficiencies that we see in substantive review it doesn't go into deficiency is that we see in filing a review those deficiencies are details and other guidance is that you can take a look at our website so for each of these common recurring deficiencies we left about 40 or so of them we make recommendations on how to address those deficiencies how to avoid those deficiencies and then we also cite two regulations and guidance in so there's other places you can look for additional information so this is the general landscape of the deficiencies that we go into pads and exclusivity x' labeling a broad swath of deficiencies related to product quality and then bioequivalence deficiencies so this is you know 40 or so deficiencies the most common ones it is not all of the deficiencies that our reviewers see during and assessment and as cook really emphasized this morning it is an applicants responsibility to submit that high-quality complete anda that we can approve in that first review cycle so for next steps this was posted in the Federal Register in January of this year I included the docket number so if you want to take a look at the guidance which I encourage you to do and also the comments associated with it you can the 60-day comment period closed in March and we are currently reviewing comments on that guidance so as I mentioned before the good and assessment practices map and this is geared towards OGD and opq to make our assessment practices more efficient and effective and it does so by doing three primary things first it says that Assessors should use templates and assessment tools to focus on the critical attributes of the application so this means that it allows Assessors to really focus on whether that's Pacific and it's the regulatory requirements for approval it further makes our internal process more efficient by clarifying the roles and responsibilities of primary Assessors secondary Assessors and division directors to reduce any duplicative classmen to reduce any duplicative work and any unnecessary work and then finally it makes it is all more effective in terms of our communications by really emphasizing that OD d & opq will clearly communicate what deficiencies must be corrected for an anda to be approved we hope that making these three changes will lead to higher quality resubmissions so when you're responding back to these deficiencies and will also reduce the number of subsequent review cycles if you go to FDA's map I included the map number here you can plug that in and then take a look at that map that's available publicly so in summary I really encourage you to review the good and a submission practices draft guidance this goes into those common deficiencies that we see over and over again and if you take a look at this it'll also make recommendations to you on how you can avoid those deficiencies that you can get your application of faster we also in addition to focusing on what applicants can do are taking steps to improve the efficiency of our internal assessment process of andas and both of these actions are really I think important process improvements that will achieve that drug competition action plan goal of review of reducing the reviews number of review cycles to approval so thank you [Applause] all right thank you so much Lisa so clearly today we've given you a lot of reading it's almost feels like you're back in college literature you have to circle back to but please you know there's a lot of really good information then there's and we really strongly encourage you to take a look at all that information and refer to the FDA website for those shortcuts so today we've mentioned a little bit about the good abbreviated new drug application practices the map itself which describes a little bit about our thinking of the assessment process so to that end we're going to go a little bit more into some of the software tools that we're exploring that will help support our Assessors as they evaluate these and of submissions again my name is Sarah Kurtz I am currently serving as an advisor and the office of regulatory operations in the office of generic drugs my background is in labeling so I do have that spin on on kind of the assessment piece and the guidance so there's essentially two things two general concepts I'd like you to take away from today from this portion of the presentations very high-level is an understanding of what we're doing to incorporate software into our assessment practices and the second being what this means to you in the public so as we're developing tools to help our Assessors and the teams we're looking at a number of different things so we're looking at what sources of information or databases are being used by our Assessors so one example being the orange book another the inactive ingredient database looking at what types of information and how it's being submitted by applicants so different Word documents data that's being supplied child data looking at PDF files all those types of sources of information we're also looking at what type of knowledge has been gained from the agency's experience with the same or similar drug products so looking at therapeutic classes and different dosage forms we're also looking at what relevant or related policy documents are used during the assessment process so while you're also looking at the guidance documents we were internally evaluating those and looking at those and trying to integrate those into our assessment piece as well and we're also looking to see are there discipline specific types of information or cross discipline connections that can be made which will help limit some of the duplicative efforts or duplicative review and then finally how does the Assessor use information from these various sources we're using it to validate or we're using it as general information or background that helps provide our a little bit more of that story are we looking at as critical information that will support our decision so when we're considering how to continue streamlining our assessment practices we're targeting how the technology can help us the sirs maximize their focus on rigorous scientific and regulatory assessments while minimizing some of the more administrative tasks or exercises so looking having to go search for data having to go look for information some of the copying and pasting to support and provide that into our templates some of the areas we've identified include the ability to automatically populate information to the discipline templates so this will help present information to the Assessor in a more efficient format looking at labeling at quality and our bio code once pieces to see what types of connections we can make across those looking to extract and apply information from each of those submission some of that standard information for example or 356 H forms what can we pull from that and present to the reviewer present to the individual that's doing that assessment we're looking to integrate information from multiple sources so as we've mentioned resoures or the Assessors evaluate or use a number of different resources to complete their assessment so how are we going to ideally some of this information could be extracted from these different databases and integrated and presented to the Assessor through a user interface to make it more efficient and another opportunity is through establishing connections across related products it's a recognizing knowledge that we find and related to one drug product may be helpful as we evaluate a similar or a related drug product so our goal is to improve knowledge management capabilities through some of these connections so essentially how will this affect the public and Industry we do anticipate greater use of software in the assessments and this will lead to greater consistency in the assessment of submissions it will facilitate connections across assessments and improve knowledge management we anticipate improvements in the timeliness during the assessment the Assessors will spend less time searching for information or populating discipline templates and can focus primarily on the assessment of the application which then lends itself to this final bullet of being able to prioritize our Assessor time so the Assessor can then be more focused on that rigorous scientific and regulatory assessment rather than some of the more administrative exercising and finding information so this does support our efforts to prioritize the time that's spent on each application and which also supports our goals of taking approval actions more quickly on and as a tactic qualifier that meet the criteria for approval we're looking to increase our first cycle approvals and also continue meeting or exceeding our good e42 commitments as you've heard today so to summarize how are we incorporating software entire assessment practices what we're looking at is a means of assembling and presenting information to the Assessor that'll help maximize their focus on that rigorous scientific and regulatory assessment and how will these tools benefit the public and industry by prioritizing our Assessor time and resources we're looking to reduce the amount of time used on more administrative pieces and be able to focus more on that actual assessment piece so as Lisa mentioned please take a look at the big good and a submission practices draft guidance please also know we are taking steps to enhance efficiency and and assessments through

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