Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned

FDA and the Center for Research on Complex Generics (CRCG) will host a free public webinar on December 6, 2022: Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned

Webinar Time:

Tuesday, December 6: 8:30 a.m. – 5:00 p.m.


This webinar is FREE. Register now. 

About the Event:

Establishing bioequivalence for drug products often involves having inactive ingredient sameness in a proposed generic’s formulation with its reference listed drug (RLD). In general, to determine whether a proposed formulation will meet FDA’s standards for sameness, the Agency provides formulation assessments through the controlled correspondence pathway. However, the challenges associated with meeting formulation sameness can differ between dosage forms and include differences in regulatory requirements for formulation sameness, analytical challenges associated with complex inactive ingredients, as well as safety considerations for exposure levels of inactive ingredients. To aid in the development of generic drug products, FDA publishes product-specific and general guidances that provide recommendations for establishing bioequivalence along with other considerations related to inactive ingredients and formulation sameness. However, even with the availability of FDA guidances and other informative tools like the inactive ingredient database, establishing formulation sameness can pose a significant challenge for generic drug applicants.

The goal of this webinar is to provide an overview of the regulatory framework, scientific concepts, product-specific challenges, and best practices related to development of complex generic drug products that are either required or recommended to have the same formulation as their respective RLDs. This information will provide a better understanding for the considerations that go into developing appropriate formulations, as well as best practices to present and support a formulation assessment that can reduce the time to potential product approval. The one-day webinar will include five sessions composed of presentations from FDA and the pharmaceutical industry followed by panel discussions to answer attendee questions.

FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.

Learning Objectives:

  • Providing an overview of the regulatory framework for formulation sameness assessment
  • Understanding the concepts related to (1) qualitative (Q1) and quantitative (Q2) formulation sameness, and (2) “no significant difference” assessments
  • Understanding the considerations for inactive ingredient levels in a formulation and the use of inactive ingredient database
  • Identifying considerations and potential challenges during formulation development
  • Providing best practices for submitting formulation assessment requests and supporting formulation sameness in ANDA submissions with an emphasis on complex generic drug products


This webinar is primarily targeted for the generic drug industry and others involved in generic drug product development, including contract research organizations (CROs) that support generic drug applications, the new drug industry, academia, and other international regulatory agencies.

Webinar Outline:

Introduction to the Webinar
At the beginning of the webinar, presenters will provide opening remarks and an overview of the webinar and its different sessions.

  • Presentations by experts from FDA and CRCG

SESSION 1: Regulatory Concepts for Formulation Sameness and Assessment
This session will provide an overview of the regulatory framework surrounding inactive ingredients as well as present the requirements and recommendations for formulation sameness across different types of drug products. Presenters will also provide some insight into FDA’s responses that generic developers may receive following a formulation assessment request, as well as a discussion on the regulatory concepts generic developers may consider when selecting an appropriate RLD or reference standard during formulation development.

  • Presentations by experts from FDA

SESSION 2: Qualitative and Quantitative Considerations for Formulation Assessments
This session will provide an overview of the concepts and factors involved with determining whether the inactive ingredients in a proposed generic formulation are qualitatively and quantitatively (Q1/Q2) the same as the RLD product. Presenters will discuss different types of inactive ingredients across various dosage forms, characterization methods that can support qualitative sameness, and the general principles for performing a quantitative sameness comparison. This approach to formulation assessment will also be compared with the “no significant difference” formulation assessment approach.

  • Presentations by experts from FDA

SESSION 3: Inactive Ingredient Database and Excipient Considerations

This session will provide information on the inactive ingredient database and related considerations to support the safe use and levels for an inactive ingredient in a proposed generic formulation. Presenters will give an overview of the inactive ingredient database and how its information can be used. Next, a discussion on the safety considerations for an inactive ingredient in a proposed generic formulation will be presented, which will include highlighting challenges when the proposed product is indicated for a pediatric population.

  • Presentations by experts from FDA

SESSION 4: Scientific Challenges and Considerations During Formulation Development

This session will provide an opportunity for industry speakers to share their experience with the scientific challenges encountered during formulation development and ensuring sameness with the RLD, whether using the qualitative and quantitative (Q1/Q2) sameness approach or the no significant difference approach. An FDA presenter will also provide an overview of the Agency’s recently published Guidance for Industry: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

  • Presentations by experts from FDA and industry

SESSION 5: Best Practices for Submitting Formulation Assessment Requests and Avoiding Information Requests

This session will provide FDA’s thoughts and recommendations for submitting an appropriate formulation assessment request. Presenters will provide details on the proposed generic formulation information that should be provided to FDA in a formulation assessment request to facilitate FDA’s assessment and avoid potential requests for additional information. Next, presenters will give an overview of the additional ways generic applicants can request information from FDA if more feedback is needed, and when these communication methods may be more suitable than a controlled correspondence formulation assessment request.

  • Presentations by experts from FDA