- May 11 - 12, 2023
- - ET
- - ET
The workshop will be hosted as a hybrid (in-person and virtual) meeting. Attendees may join in person at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center Room 1503, Sections B&C, Silver Spring, MD 20993. Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during the free registration for this workshop and are encouraged to register early. Remote attendees may participate virtually via Zoom.
About This Workshop
The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2024 Generic Drug User Fee Amendments (GDUFA) science and research priorities.
The topics discussed during the workshop will encompass challenges and considerations for oral, parenteral, and other generic products, including complex products. The sessions of this year’s workshop will discuss the research needed to address challenges for generic product development related to:
- Methods to Address Impurities in Generic Products such as Nitrosamines
This session will discuss what research is needed to develop efficient bioequivalence standards for products that are reformulated to mitigate potential risks of nitrosamines, such as elucidating excipient effects related to nitrosamine impurity formation, addressing potential concerns related to the mutagenicity or carcinogenicity of reactive impurities in certain drug products, and identifying other aspects of emerging issues related to nitrosamines.
- Bioequivalence Approaches for Generic Oral Products
This session will discuss what research is needed to address bioequivalence issues related to oral routes of administration, such as expanding the scope of biowaivers, integrating in vitro and in silico modeling evidence, advancing research on clinically relevant dissolution testing, and supporting global harmonization (e.g., International Council for Harmonisation M13 that intends to harmonize bioequivalence (BE) standards for immediate-release solid oral dosage forms) across regulatory agencies.
- Equivalence Assessments for Generic Products with Complex Active Ingredients
This session will discuss what research is needed to improve methods for characterizing active pharmaceutical ingredients (APIs) and associated impurities and immunogenicity, particularly for peptide and oligonucleotide products, and specifically related to the development of methods and standards for peptide immunogenicity bioassays. This session will also discuss what research is needed to advance comparative analysis of complex APIs and associated considerations.
- Bioequivalence Approaches for Generic Dosage Forms and Formulations
This session will discuss what research is needed to improve methods for characterizing complex formulations and excipient effects, focusing on complex injectable products including long-acting injectable, insertable or implantable (collectively, LAI) products, as well as qualitative (Q1) and quantitative (Q2) formulation comparability challenges for complex and non-complex (e.g., injectable) products. This session will also discuss what research is needed to address challenges related to the device constituent parts of injectable products.
- Bioequivalence Approaches for Complex Generic Inhalation Products
This session will discuss what research is needed to improve alternative bioequivalence approaches for orally inhaled drug products (OIDPs), such as identifying the types of evidence that could justify other than minor differences in the device constituent part of an OIDP and addressing any emerging challenges for generic products associated with transitioning to low global warming propellants.
- Bioequivalence Approaches for Complex Generic Topical Products
This session will discuss what research is needed to improve alternative bioequivalence approaches for topical drug products, such as addressing challenges with implementing in vitro bioequivalence methods, and expanding efficient characterization-based bioequivalence approaches for “Q3 Similar” topical generic products.
A common theme across the sessions of the workshop will be to consider what research is needed to overcome challenges for generic product development by establishing approaches that integrate evidence from empirical tests or studies with evidence from computational modeling and simulation. Each session of this year’s workshop will include presentations and a panel discussion with representatives from the generic drug industry and FDA. The workshop will include an open comment session where attendees will be able to provide live comments during the event. Specific presentations and discussions at this workshop will be announced at a later date.
Hybrid (Virtual and In-Person) Options for Attendance
There is no cost to attend the event. Registrants will have two options to attend this public workshop. The workshop will be held on the FDA’s White Oak Campus (10903 New Hampshire Ave, Building 31 Conference Center Room 1503, Sections B&C, Silver Spring, MD 20993). Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during registration for this workshop and are encouraged to register early. Remote attendees may participate virtually via Zoom. For parking and security information, please refer to Visitor Information.
Members of the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.
FDA wants your input
FDA seeks ideas on generic drug research topics from the drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2024 research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2024 GDUFA Science and Research Priorities by submitting a comment on the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of June 12, 2023.
|Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop Agenda||pdf (189.98 KB)|
|FY23 GDUFA Workshop Headshots and Bios||pdf (2.01 MB)|