The Center for Complex Generics

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

• Download the agenda
• Download the speaker bios

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

Audience:

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 Recordings: 

• 2022 Excipients and Formulation Assessments Welcome & Opening Remarks
• 2022 Excipients and Formulation Assessments Session 1 Presentations & Panel Discussion
• 2022 Excipients and Formulation Assessments Session 2 Presentations & Panel Discussion
• 2022 Excipients and Formulation Assessments Session 3 Presentations & Panel Discussion
• 2022 Excipients and Formulation Assessments Session 4 Presentations & Panel Discussion
• 2022 Excipients and Formulation Assessments Session 5 Presentations, Panel Discussion, Closing

Webinar Slides:

Welcome and Opening Remarks
James Polli, PhD, Co-Director, CRCG
Anna Schwendeman, PhD, Co-Director, CRCG

Webinar Overview - Importance of Formulation in Generic Drug Development
Darby Kozak, PhD, Deputy Director, DTP‐I, ORS, OGD, FDA

SESSION 1: Regulatory Concepts for Formulation Sameness and Assessment

Introduction to Session 1
Colleen Lee, JD, Acting Deputy Division Director, DLRS, OGDP, OGD, FDA

Requirements and Recommendations Related to Inactive Ingredients
Melissa Mannion, PharmD, JD, Regulatory Counsel, DPD, OGDP, OGD, FDA

FDA Responses to Questions on QQ Sameness
Melissa Mannion, PharmD, JD, Regulatory Counsel, DPD, OGDP, OGD, FDA

Formulation Considerations for Selecting an Appropriate RLD or RS
Timothy H. Kim, PharmD, Acting Director, DOBPRA, OGDP, OGD, FDA

Q&A Session with Panel

• Moderator: Colleen Lee, JD Acting Deputy Division Director, DLRS, OGDP, OGD, FDA
• Panelists:
  Melissa Mannion, PharmD, JD, Regulatory Counsel, DPD, OGDP, OGD, FDA
  Timothy H. Kim, PharmD, Acting Director, DOBPRA, OGDP, OGD, FDA
  Priyanka Ghosh, PhD, Senior Pharmacologist, DTP‐I, ORS, OGD, FDA
  Truong‐Vinh (Vinh) Phung, PharmD, Supervisory Pharmacist, DFR, ORO, OGD, FDA

SESSION 2: Qualitative and Quantitative Considerations for Formulation Assessments

Introduction to Session 2
Bryan Newman, PhD, Lead Pharmacologist, DTP‐I, ORS, OGD, FDA

Considerations for the Qualitative Sameness Evaluation of a Proposed Generic Formulation
Yan Wang, PhD, Team Lead, DTP‐I, ORS, OGD, FDA

General Considerations for the Quantitative Sameness Evaluation of a Proposed Generic Formulation
Anubhav Kaviratna, PhD, Staff Fellow, DTP‐I, ORS, OGD, FDA

General Considerations for the “No Significant Difference” Evaluation of a Proposed Generic Formulation
Megan Kelchen, PhD, Pharmacologist, DTP‐I, ORS, OGD, FDA

Q&A Session with Panel

• Moderator: Bryan Newman, PhD, Lead Pharmacologist, DTP‐I, ORS, OGD, FDA
• Panelists:
  Yan Wang, PhD, Team Lead, DTP‐I, ORS, OGD, FDA
  Anubhav Kaviratna, PhD, Staff Fellow, DTP‐I, ORS, OGD, FDA
  Megan Kelchen, PhD, Pharmacologist, DTP‐I, ORS, OGD, FDA
  Colleen Lee, JD, Acting Deputy Division Director, DLRS, OGDP, OGD, FDA
  Hiren Patel, PhD, Staff Fellow, DB‐II, OB, OGD, FDA

SESSION 3: Inactive Ingredient Database and Excipient Considerations

Introduction to Session 3
Michelle Lin, MD, Senior Physician, DCR, OSCE, OGD, FDA

Inactive Ingredient Database Overview
Susan Zuk, MS, Branch Chief, DRGS, OPPQ, OPQ, FDA

General Approach to Safety Assessment of Excipients in Generic Formulations
Stuti Agarwal, PhD, Staff Fellow, DPTR, OSCE, OGD, FDA

General Approach to the Safety Review of Pediatric Excipients
Amrita Ghosh, MD, PhD, Lead Physician, DCR, OSCE, OGD, FDA

Q&A Session with Panel

• Moderator: Michelle Lin, MD, Senior Physician, DCR, OSCE, OGD, FDA
• Panelists:
  Susan Zuk, MS, Branch Chief, DRGS, OPPQ, OPQ, FDA
  Stuti Agarwal, PhD, Staff Fellow, DPTR, OSCE, OGD, FDA
  Lisa Faulcon, PhD, Division Director, DCR, OSCE, OGD, FDA
  Bryan Newman, PhD, Lead Pharmacologist, DTP‐I, ORS, OGD, FDA
  Yi Zhang, PhD, Lead Pharmacologist, DB‐III, OB, OGD, FDA
  

SESSION 4: Scientific Challenges and Considerations During Formulation Development

Introduction to Session 4
Pamela Garner Dorsey, PhD, Senior Pharmacologist, DB‐III, OB, OGD, FDA

Scientific Challenges Related to Establishing Q1/Q2 Sameness – An Industry Perspective
Nitin Bhattad, MPharm, Global Head of Regulatory Science, Viatris, Inc.

Specificity & Discriminatory Challenges Limiting Accurate, Complete Identification and Quantification of Excipients in RLD Deformulation
Babita Mallick, PhD, Team Lead, Analytical Development, Sandoz Inc

Overview of the Guidance for Industry: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Xinran Li, PhD, Pharmacologist, DB‐II, OB, OGD, FDA

Q&A Session with Panel

• Moderator: Pamela Garner Dorsey, PhD, Senior Pharmacologist, DB‐III, OB, OGD, FDA
• Panelists:
  Nitin Bhattad, MPharm, Global Head of Regulatory Science, Viatris, Inc.
  Babita Mallick, PhD, Team Lead, Analytical Development, Sandoz Inc.
  Melissa Mannion, PharmD, JD, Regulatory Counsel, DPD, OGDP, OGD, FDA
  Hiren Patel, PhD, Staff Fellow, DB‐II, OB, OGD, FDA
  Yan Wang, PhD, Team Lead, DTP‐I, ORS, OGD, FDA
  

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

Introduction to Session 5
Truong‐Vinh (Vinh) Phung, PharmD, Supervisory Pharmacist, DFR, ORO, OGD, FDA

Tips for Submitting a Proposed Formulation Table
Elizabeth Kim, MSN, Controlled Correspondence Coordinator, DFR, ORO, OGD, FDA

Pathways for Receiving FDA’s Feedback on Formulations
Truong‐Vinh (Vinh) Phung, PharmD, Supervisory Pharmacist, DFR, ORO, OGD, FDA

Q&A Session with Panel

• Moderator: Truong‐Vinh (Vinh) Phung, PharmD, Supervisory Pharmacist, DFR, ORO, OGD, FDA
• Panelists:
  Elizabeth Kim, MSN, Controlled Correspondence Coordinator, DFR, ORO, OGD, FDA
  Julia Lee, PharmD, Deputy Division Director, DFR, ORO, OGD, FDA
  Melissa Mannion, PharmD, JD, Regulatory Counsel, DPD, OGDP, OGD, FDA
  Bryan Newman, PhD, Lead Pharmacologist, DTP‐I, ORS, OGD, FDA
  

Closing Remarks
Bryan Newman, PhD, Lead Pharmacologist, DTP‐I, ORS, OGD, FDA

For More Information: If you have any questions about this workshop please contact info@complexgenerics.org.