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FY 2021 GDUFA Science and Research Report

FDA March 09, 2022

Tag: GDUFA Science , generic drug , Research Report

The FY 2021 GDUFA Science and Research report provides detailed results for 13 areas of focus, each including a summary of research activities, research highlights, comprehensive lists of new, ongoing, and completed grants and contracts, and outcomes generated from the GDUFA-funded Science and Research program in FY 2021. The outcomes include a list of general guidances and product-specific guidances (PSGs) issued in FY 2021 that resulted from relevant research, as well as lists of journal articles, posters, and presentations given in FY 2021. Additional information on outcomes from the GDUFA Science and Research program are shared in the separate GDUFA Science and Research Outcomes Reports, posted here.

Directors of CDER’s Office of Generic Drugs and Office of Pharmaceutical Quality 

The GDUFA Science and Research program supports the development of innovative methodologies and more efficient tools to help establish drug equivalence standards and support the development of safe, effective, and high-quality generic drug products for the American public. This research is particularly important for certain pharmaceutical products, known as complex products, which are harder to develop as generics. Complex products often have few generics, or none at all. In the absence of market competition among generic alternatives, these medicines can be so expensive that patients who need them may not be able to afford them.

The outcomes from GDUFA-funded research expand our understanding of these complex products and often contribute to the development of advanced methods to characterize product quality and performance. These methods may play a critical role in determining how FDA evaluates the quality and bioequivalence of complex generic products and establish the scientific basis for novel and more efficient pathways by which to develop complex generics. Bioequivalence and quality recommendations are communicated to the generic industry, such as through the continual publication of new and revised product-specific guidances (PSGs), as well as general guidances for industry. 

We are deeply grateful to all of our collaborators within FDA and at institutions around the world, and our stakeholders throughout the global generic drug industry. There remain numerous challenges to face, and we look forward with optimism and we remain confident that our collaborations to advance the GDUFA Science and Research Program are the most effective way to address scientific challenges for complex generics, and to enhance patient access to high quality, safe, and effective medicines.

Read the full FY 2021 GDUFA Science and Research Report Joint Directors' Message here.

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FDA releases FY23 GDUFA Science and Research Report

https://www.fda.gov/drugs/generic-drugs/fy-2023-gdufa-science-and-research-report?utm_medium=email&utm_source=govdelivery

In FY 2023, research projects on impurities specifically focused on N-nitrosamines impurities including NDSRIs in drug products. FDA’s research efforts involved one external research contract and one external research grant, as well as many internal research projects related to nitrosamines impurities. These research projects continued to develop analytical procedures for the quantitation of N-nitrosamine impurities (small molecule nitrosamines and NDSRIs) in pharmaceuticals, assessing the risk of forming these impurities, toxicological risks of these impurities, exploring strategies to prevent or mitigate their formation by reformulating drug products potentially with suitable antioxidants or pH modifiers, and weighing the potential impacts of reformulations on the bioequivalence of generic products.

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FY 2023 GDUFA Science and Research Report

FDA’s generic drug Science and Research Program created under the Generic Drug User Fee Amendments (GDUFA) is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research collaborations among FDA scientists and through multiple collaborations with research institutions worldwide.

GDUFA-funded research aims to improve the efficiency with which generic drugs can be developed and assessed, and benefits public health in two critical ways:

• making it more feasible for manufacturers to develop generic drugs, which can reduce the risk of drug shortages and facilitates competition; and
• enhancing patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need.

Each year, multiple sources of public input help FDA identify specific generic drug science and research priorities that can help expand and accelerate patient access to generic drugs. FDA then advances research in those scientific areas and publishes reports that correspond to these activities and their outcomes. In FY 2023 eight scientific areas were identified as GDUFA Science and Research Priority Initiatives. Accordingly, this FY 2023 GDUFA Science and Research report describes active research projects and outcomes organized into eight chapters corresponding to the eight priority areas with a ninth chapter reporting on additional generic drug  

Table of Contents

(Each link below will open a 19 MB PDF)

Joint Directors’ Message 

The GDUFA science and research program facilitates patient access to high-quality, safe, and effective generic drugs. It does this by advancing research in areas where generic product development has been limited due to scientific knowledge gaps. For example, an insufficient scientific understanding can create uncertainty about how to develop a complex generic product, or how to demonstrate that it is bioequivalent to its brand name reference listed drug product. Each fiscal year, experts across the generic drug industry collaborate with FDA to establish research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the FDA then strategically design research projects and studies so that the research outcomes enable FDA to build scientific bridges across the knowledge gaps. The outcomes of this research help FDA establish efficient new approaches for pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop, thus making these generic medicines available for patients.

Read the full FY 2023 GDUFA Science and Research Report  Joint Directors' Message .

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FY 2022 GDUFA Science and Research Report – Impressive Findings and Conclusions

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If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into.  The FY 2022 GDUFA Science and Research Report ( here ) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for complex products, and avenues for further research into topics of interest for the FDA and the generic drug industry, all in an effort to meet the challenges of new, innovative NDA products and the development pathways for follow-on generics.

The report notes that “[I]n FY 2022, FDA issued 177 new and revised PSGs (59 of which were for complex products) that provided recommendations for developing generic drugs and generating the evidence to support ANDA approval.  This included 117 PSGs for products (including 41 PSGs for complex products) with no approved ANDAs at the time of PSG publication.  Also, 18 PSGs were revised in FY 2022 to add an efficient in vitro BE option.”  Many of the guidances developed provide alternate, less burdensome methods of establishing bioequivalence through other than in vivo methods, using learning from the research conducted or funded by the GDUFA science and research program.  Others provide complex studies over long periods of time, but are certainly better than not having a pathway at all other than comparative bioequivalence studies with clinical endpoints.

The FY 2022 GDUFA Science and Research Report describes active and completed research projects and outcomes that are organized into thirteen scientific areas, which include:

• Ophthalmic Products
• Complex Mixtures and Peptide Products
• Long-Acting Injectable, Insertable, or Implantable Products
• Complex Injectables, Formulations, and Nanomaterials
• Inhalation and Nasal Products
• Topical Products
• Locally-Acting Physiologically Based Pharmacokinetic Modeling
• Quantitative Clinical Pharmacology
• Oral Absorption Models and Bioequivalence
• Patient Substitution of Generic Drugs
• Abuse-Deterrent Opioid Drug Products
• Data Analytics
• Drug-Device Combination Products

The sections are rife with examples describing the practical implications of the research project, including approvals that have resulted from application of the research, along with links to PSGs that resulted from the same, as well as articles to reference for further insight.  I think that approaching this report should be like the proverbial answer to the question “How do you eat an elephant?”  “One bite at a time.”  Lots to learn in this report!  Enjoy!

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FDA Lists GDUFA Research Priorities for FY 2023

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FDA prepares a yearly list of regulatory science priority initiatives for generic drugs as part of a commitment in the Generic Drug User Fee Amendments of 2017 (GDUFA II). These priority initiatives are chosen based on input from FDA, industry and other stakeholders.

The annual report reflects the GDUFA-funded research activities carried out by FDA and external grantees. Research activities follow the FY2019 GDUFA Regulatory Science Priority Initiatives , which fall broadly into the following categories:

• Complex active ingredients, formulations, or dosage forms
• Complex routes of delivery
• Complex drug-device combination products
• Tools and methodologies for bio-equivalence and sustainability evaluation

GDUFA-funded research activities:

The report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts that the GDUFA Science and Research program awarded in FY2019. 

• Joint Directors’ Message
• Abuse-deterrent Opioid Drug Products
• Complex Injectables, Formulations and Nanomaterials
• Complex Mixtures and Peptides
• Data Analytics
• Drug-Device Combination Products
• Inhalation and Nasal
• Locally-Acting Physiologically-Based Pharmacokinetic Modeling
• Long-Acting Injectables and Implants
• Oral Absorption Models and Bioequivalence
• Patient Substitution
• Quantitative Clinical Pharmacology
• Topical Dermatological

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Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery

Miyoung yoon.

1 Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, USA

Andrew Babiskin

Sam g. raney.

2 Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, USA

Lanyan Fang

Associated data.

Quantitative methods and modeling (QMM) are rapidly demonstrating their potential to support generic drug development and assessment. This commentary is based on the public input from the Generic Drug User Fee Amendments (GDUFA) Science and Research Initiative Public Workshop held in May 2022, which recognized the implementation of model‐integrated evidence (MIE) as a high research priority for the next 5 years.

On May 9 and 10, 2022, the US Food and Drug Administration (FDA) hosted the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiative Public Workshop as a commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II). The workshop provided updates on current science and research initiatives and solicited public input on the prioritization of scientific issues impacting generic product development and approval that will shape the next 5 years of the GDUFA science and research program (known as GDUFA III, 2022–2027). This commentary will focus on QMM, which was highlighted as one of the key research priorities in this workshop.

GDUFA science and research have focused on QMM as one of the two key drivers of innovation for generic drugs along with in vitro product characterization. 1 The annual science and research initiative public workshops, including this year's, have included a session dedicated to discussing research needs and priorities for QMM. Quantitative models can support product development and regulatory decisions where bioequivalence (BE) is challenging to demonstrate or assess because the empirical evidence for BE may be impractical to sufficiently demonstrate BE. This integration of evidence from empirical tests or studies and computational models has been referred to as model‐integrated evidence (MIE). 2

At the workshop, MIE was one of key topics of the opening session titled “The Next Five Years of the Generic Product Science and Research Program.” The session explored generic industry perspectives about the challenges impacting generic product development that are the most critical to address by GDUFA research initiatives during the next 5 years. Some of the key product development challenges and BE issues were associated with complex products, such as orally inhaled drug products (OIDPs) and long‐acting injectable, implantable, and insertable products (collectively, LAI products). Industry representatives' feedback also highlighted complex BE issues in other product areas, including noncomplex generics.

In general, for the GDUFA science and research program, industry has utmost interest in prioritizing research that helps address the current challenges generic drug developers are facing. For MIE, industry is particularly interested in MIE implementation, precedents set through access to MIE case studies for regulatory purposes, and detailed guidance (e.g., recommendations in the product‐specific guidances) for those challenging areas. As indicated by Figure  1 , articles included in this special issue contain the summaries of the two most recent modeling focused public workshops organized by the FDA in collaboration with the Center for Research on Complex Generics (CRCG), engaging multiple stakeholders, including generic industry, academia, and government, 3 , 4 as well as this FDA public workshop. We believe the progress we have seen in MIE is attributable to the FDA's continuous investment in research and dissemination of outcomes advancing QMM in collaboration with experts in academia and other stakeholders as well as industry's efforts to leverage and adopt innovative QMM approaches in their development programs.

Covered FDA/CRCG and FDA workshops in the Issue. For full citation details of the listed articles for the September 30 to October 1, 2021, workshop and November 30, 2021, workshop, refer to “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview” by Babiskin et al. and “Establishing the Suitability of Model‐Integrated Evidence to Demonstrate Bioequivalence for Long‐Acting Injectable and Implantable Drug Products: Summary of Workshop” by Gong et al., respectively, in this issue. CRCG, Center for Research on Complex Generics; FDA, US Food and Drug Administration; GDUFA, Generic Drug User Fee Amendments.

The significant shift in the scope of industry's MIE feedback from development to implementation is consistent with the recent increase in submission of modeling and simulation‐based alternative BE approaches to the FDA in abbreviated new drug applications (ANDAs) and pre‐ANDA interactions. The increase is particularly notable for pre‐ANDA interactions during the past 3 years mirroring industry's strong interest and recognition of the potential MIE can bring to generic drug development programs and regulation submissions (Figure  2 ). The interactions were mainly for complex products, such as LAIs and OIDPs, whereas some noncomplex drug products were also included, such as certain oral drug products for oncology/rare disease drug products. These submissions generally leveraged GDUFA research outcomes, both the FDA internal and external research progresses and outcomes. Notably, the FDA and industry are collaboratively advancing the field and establishing the ecosystem for the application of QMM to aid the development of generic drug products.

Number of pre‐ANDA interactions with industry proposed MIE during GDUFA II. Note that the numbers of pre‐ANDA interactions include pre‐ANDA meetings and controlled correspondences. ANDA, abbreviated new drug application; GDUFA, Generic Drug User Fee Amendments; MIE, model‐integrated evidence.

According to the interviews the CRCG conducted with the generic drug industry, industry is strongly interested in applying MIE approaches as an alternative to conventional end point BE studies for inhalation and LAI products to their product development programs. Industry is looking for guidance in the implementation and validation of MIE in their submissions to the FDA and indicates the most effective way may be through publications of case studies of MIE for complex generics approvals. Such cases are expected to spur the adoption of modeling into practice in product development and regulatory submissions. The perspectives shared by multiple industry representatives were consistent with the CRCG interview.

Another feedback was on enhancing communications. Specifically, detailed MIE case studies representing the FDA's current thinking and expectations on MIE for regulatory applications, can be effectively disseminated through organizing workshops and other communication means, in addition to scientific publications. We note that the FDA is dedicated to actively publishing the progresses and case examples of MIE from the GDUFA research and there are several publications in the complex products including orally inhaled, long‐acting injectable/implant, and dermal products. 5 , 6 , 7 , 8 In addition, we believe that this special issue will provide a useful summary of the most recent development and discussion around the application of MIE to generic drug product development and assessment. The annual GDUFA science and research reports are another resource to check out the progress in MIE, which include a summary of research activities, research highlights, comprehensive lists of new, ongoing, and completed grants and contracts, and outcomes generated from the GDUFA‐funded science and research program in each fiscal year.

In‐depth industry feedback on implementing QMM approaches for specific products including OIDPS, LAIs, and orally administered products can be found in the Supplementary Material .

Overall, industry recognizes: (i) the benefits that standardizing MIE approaches for both complex and noncomplex generics would bring them; (ii) the value of using population pharmacokinetic (PK) and physiologically‐based pharmacokinetic (PBPK) modeling to replace or reduce in vivo BE studies; and (iii) the need for model validation and verification for regulatory assurance in such MIE applications. With regard to industry's desire for guidance/criteria for model validation and verification, the two specific FDA workshops discussed best practices and practical implementations of MIE (see detailed summaries in this special issue).

In the modeling focused FDA/CRCG and FDA GDUFAII workshops, the concept of model‐master file and its application to facilitate generic drug development, regulatory submission, and assessment, was introduced by the Office of Generic Drugs at the FDA. The aim of this concept is to provide a framework for communication of regulatory acceptable modeling practices allowing for increased confidence in industry use of QMM. Harmonization with other agencies, such as the European Medical Agency, for modeling and simulation for BE were also commented to be helpful. Other noteworthy comments include that as generic drug field is maturing, MIE may become a routine alternative to BE studies in support of product life cycle management such as post‐approval changes. In general, PBPK modeling has already been recommended for biopharmaceutical applications and been increasingly applied for supporting bioequivalence assessment. 9 In addition, industry suggested that the innovative approaches that the Agency used specifically to address the unexpected challenges in BE during coronavirus disease 2019 (COVID‐19) may be applied broadly with further research.

Finally, the value of artificial intelligence (AI) and machine learning (ML), potentially combined with real‐world evidence/data, in advancing the development of complex generics has been well‐recognized by industry, regulatory agency, and other stakeholders, thus the need for further research has been emphasized. Specifically, AI and ML may demonstrate their utility in optimizing the program design and reduce study duration; in utilizing public domain information (e.g., drug labeling) to facilitate unique study designs for complex generic drug product or exploratory studies on related compounds in support of generic development. In addition, Industry's feedback was focused on research that can help establish the framework and potential regulatory pathway of translating such data‐driven technologies into regulatory submissions. We also note that ML/AI technologies have been applied as part of MIE, for example, these technologies can support the model building process contributing to standardization of MIE processes for BE. 10

The challenges shared by Industry are consistent with what the FDA has regarded as opportunities for MIE. FDA's GDUFA research programs in QMM have made significant investment and generated useful outcomes over the past few years. Industry recognizes the value of MIE to address challenges in generic drug development and assessment and strongly supports the FDA's investment on research that can facilitate and accelerate MIE implementation. The FDA is committed to continue further advancing this area and included facilitating the utility of MIE to support demonstrations of BE as one of the priority areas for the next 5 years of the GDUFA Science and Research Program. Overall, it is evident that both the FDA and industry are collaboratively establishing an MIE ecosystem in generic drug development and assessment.

FUNDING INFORMATION

No funding was received for this work.

CONFLICT OF INTEREST STATEMENT

The opinions expressed in this paper are those of the authors and should not be interpreted as the position of the US Food and Drug Administration. The authors declared no competing interests for this work.

Supporting information

Appendix S1.

Yoon M, Babiskin A, Hu M, et al. Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery . CPT Pharmacometrics Syst Pharmacol . 2023; 12 :552‐555. doi: 10.1002/psp4.12930 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

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Advancing Generic Drug Development: Translating Science to Approval 2023 September 13-14, 2023

The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA, and ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development.

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The agenda is still being refined and may be updated over time. The current version is v5, uploaded on August 14, 2023.

The speaker biographies document provides detailed information for each of the workshop presenters.

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