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  4. Navigating Controlled Correspondences to Support Generic Drug Development - 02/27/2025
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Virtual | Virtual

Event Title
Navigating Controlled Correspondences to Support Generic Drug Development
February 27, 2025

Date:
February 27, 2025
Time:
1:00 p.m. - 3:30 p.m. ET

Topics & PresentationsSpeakers
Mastering Controlled Correspondences: What, When, and HowYan Wang, PhD
Deputy Director
Division of Therapeutic Performance I (DTP I)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER
Controlled Correspondence on Clinical Pharmacology Topics in Generic Drug DevelopmentMark Donnelly, PhD
Senior Pharmacologist
Division of Quantitative Methods and Modeling (DQMM)
ORS | OGD | CDER
Navigating Formulation Assessment: Considerations When Preparing the Q1/Q2 Sameness InquiryQiangnan Zhang, PhD
Staff Fellow
DTP I | ORS | OGD | CDER
Navigating Formulation Assessment: Considerations for Products that are Not Required to be Q1/Q2Ying Jiang, PhD
Chemist
DTP I | ORS | OGD | CDER
Exploring Bioequivalence Considerations for Controlled Correspondences: Assessment and Best PracticesPamela Dorsey, PhD
Senior Pharmacologist
Division of Bioequivalence III (DB III)
Office of Bioequivalence (OB)
OGD | CDER
The Role of Controlled Correspondences in Supporting Safety Assessments in Generic Drug DevelopmentChristopher Morgan, PhD
Pharmacologist
Division of Pharmacology/Toxicology Review (DPTR)
Office of Safety and Clinical Evaluation (OSCE)
OGD| CDER
Discussion PanelModerator:
Priyanka Ghosh, PhD
Lead Pharmacologist
DTP I | ORS | OGD | CDER 

Panelists:
Robert Lionberger, PhD
Director
ORS | OGD | CDER 

Partha Roy, PhD
Director
Office of Bioequivalence (OB)
OGD | CDER 

Bill Chong, MD
Director
OSCE | OGD | CDER
Q&A SessionYan Wang, Mark Donnelly, Qiangnan Zhang, Ying Jiang, Pamela Dorsey, and Christopher Morgan
Closing RemarksRobert Lionberger

AGENDAExternal Link Disclaimer

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT (Hosted by CDER SBIA)

The FDA’s Office of Generic Drugs (OGD) plays a critical role in ensuring access to safe, effective, and affordable generic drugs. To facilitate the development and approval process, the FDA offers various pathways for communication, including controlled correspondence.

This event offers a comprehensive overview of controlled correspondence as an efficient pathway for communication with the FDA regarding generic drug development. FDA will host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA experts.

INTENDED AUDIENCE

This webinar is designed for generic drug developers and regulatory professionals looking to streamline their interactions with the FDA with the usage of Controlled Correspondence.

TOPICS

  • Navigating
    • formulation assessments
    • controlled correspondences related to bioequivalence approaches/studies
  • Clinical pharmacology topics in generic drug development
  • Role of controlled correspondences in supporting the safety evaluation of generic drugs

SPEAKERS and PANELISTS (see AGENDAExternal Link Disclaimer )

FDA RESOURCES

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