Demonstrating Equivalence of Generic Complex Drug Substances and Formulations
The workshop is free to attend and open to the public.
The FDA is continually interested in new analytical methods and innovative in vitro testing methodologies that support establishment of equivalence of generic drug products and facilitate the regulatory review process. Complex drug substances (e.g., peptides, polymers, and naturally derived drug substances) and complex formulations (e.g., liposomes, emulsions, suspensions, and polymeric materials) present unique development and regulatory challenges for demonstrating active ingredient sameness and/or bioequivalence. New analytical tools and in vitro tests may overcome these hurdles and thereby reduce product development time and cost, and inform regulatory decisions. To help support the development of these new tools, fees from the first Generic Drug User Fee Amendments (GDUFA I: 2012-2017) were allocated to regulatory science initiatives based on public and industry input.
In this workshop on complex drug development, the FDA will highlight outcomes and impacts from GDUFA I research related to complex drug products as well as:
- Share FDA’s current experiences on the evaluation and characterization of critical quality attributes for complex drug substances and formulations.
- Discuss current and future innovative approaches for the development and regulatory review of complex drug product equivalence.
- Obtain input from various stakeholders on how to conduct and assess critical quality attribute measurements to demonstrate equivalence of complex drug products; and
- Request comments on these topics.
To register, go to: Complex Drug Workshop Registration on or before Sept 30, 2017. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m. Webcast Link for Online Attendees: https://collaboration.fda.gov/complexgenericdrugs/. Please log-in as guests.
The workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503 B+C), Silver Spring, MD 20993-0002.
Visitors attending public meetings in the Building 31 Great Room must enter through Building 1 where they will undergo the routine security check procedures for building entry. A visitor badge and escort are not required to attend a public meeting in the Great Room. Please allocate 15 - 30 min for arrival and security checks. Driving and parking information for visitors to the FDA, along with a campus map, can be found at: FDA White Oak Campus Visitor Information
Introduction to Complex Products
Science and Generic Drugs (Dr. John Peters) (PDF - 657 KB)
Session I: Demonstrating Complex API Sameness
Comparative immunogenicity assessment of impurities in drug products (Dr. Daniela Verthelyi)
Session II: Characterization of Complex Excipients and Formulations
Session III: Novel IVRT for Complex Formulations
- Introduction: Novel IVRT for Complex Formulations (Dr. Darby Kozak) (PDF - 597 KB)
- Part 3: https://collaboration.fda.gov/p2wxegqlmmv/
FOR FURTHER INFORMATION CONTACT: Darby Kozak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4710, Silver Spring, MD 20993, 240-402-2647, email: Darby.Kozak@fda.hhs.gov; or Xiaohui Jiang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4716, Silver Spring, MD 20993, 240-402-7964, email: Xiaohui.Jiang@fda.hhs.gov.
Additional details will be posted as they are available. Please check the Federal Register and this website in the coming weeks.