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  1. News & Events for Human Drugs

Demonstrating Equivalence of Generic Complex Drug Substances and Formulations

October 6, 2017 (8:00 a.m. – 4:00 p.m.), FDA White Oak Campus

The workshop is free to attend and open to the public.

Complex Drug Workshop Registration

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:

  1. Share FDA’s current experiences on the evaluation and characterization of critical quality attributes for complex drug substances and formulations. 
  2. Discuss current and future innovative approaches for the development and regulatory review of complex drug product equivalence.
  3. Obtain input from various stakeholders on how to conduct and assess critical quality attribute measurements to demonstrate equivalence of complex drug products; and
  4. Request comments on these topics.

To register, go to: Complex Drug Workshop Registrationdisclaimer icon 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

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Meeting Materials


Introduction to Complex Products

Session I: Demonstrating Complex API Sameness

Session II: Characterization of Complex Excipients and Formulations

Session III: Novel IVRT for Complex Formulations

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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: [email protected]; 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: [email protected].

Additional details will be posted as they are available. Please check the Federal Register and this website in the coming weeks.

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