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Workshop | Virtual

Event Title
FDA/Center for Research on Complex Generics (CRCG) Workshop on Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment
December 1 - 2, 2026

Date:
December 1 - 2, 2026
Day1:
Tue, Dec 01 8:00 a.m. - 05:45 p.m. ET
Day2:
Wed, Dec 02 8:00 a.m. - 04:00 p.m. ET
Location:
Event Location
Attend In Person or Virtually
In Person: The Universities at Shady Grove
Building II

9630 Gudelsky Drive
Rockville, MD 20850
United States


This workshop is free to attend virtually

Register Here

Event Details

This 2-day hybrid workshop brings together FDA, industry, and academic experts to address the most pressing scientific and regulatory challenges of long-acting injectable (LAI) generic drug development.

The program will include a series of expert-led presentations and interactive discussions to examine current challenges and consider emerging solutions related to generic LAI product development and regulatory assessment, including:

  • Formulation and excipient characterization strategies
  • Drug release mechanisms and in vitro release testing (IVRT) method development
  • Totality of evidence frameworks
  • Bioequivalence approaches and innovative pharmacokinetic (PK) study designs
  • The application of model-integrated evidence to accelerate LAI generic development
  • Regulatory expectations for complex LAI ANDA submissions
  • Common abbreviated new drug application (ANDA) deficiencies

From complex excipient characterization and reverse engineering to IVRT and PK study design, LAI generic development commonly spans formulation science, analytical chemistry, modeling, and regulatory strategy.

The discussions and structured activities will explore connections between drug release mechanisms, relevant in vitro methodologies, and predictive modeling approaches, with a focus on defining their current utility in specific regulatory contexts.

Workshop participants will gain valuable insights into the intricacies of developing generic LAI products across a range of dosage forms, including drug substance suspensions, polymeric microspheres, implants, in situ forming depots, etc.

Virtual Attendance

All attendees will enjoy a series of expert-led presentations and panel discussions that provide valuable insights into critical aspects of generic LAI product development including formulation, excipient characterization, and manufacturing considerations; drug release mechanisms and the role of IVRT studies to support a demonstration of bioequivalence; novel in vivo PK study designs; and the use of model-integrated evidence. Virtual attendees will be able to:

  • Attend all presentations and panel discussions
  • Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
  • Enjoy free access to workshop recordings of presentations and panel discussions (excluding the in-person-only sessions)

In-Person Attendance

In-person attendees will enjoy all the benefits of virtual attendance and, additionally, interact directly with experts from FDA, academia, industry, consulting groups, and others to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends. These high-engagement scientific interactions will be facilitated through two in-person-only sessions:

  • A session dedicated to informal networking and candid dialogue with FDA, industry, academic, and other subject matter experts about scientific and regulatory challenges for complex LAI products.
  • A guided session for small groups of in-person attendees including real-world case studies and consensus mapping to identify priorities and actionable outcomes by working through challenging issues for LAI formulation and excipient characterization, IVRT method development, bioequivalence approaches, and model-integrated evidence strategies.

For more information, please visit the Center for Research on Complex Generics website.

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