Agenda Now Available: FDA/CRCG Free Public Workshop: In Vitro Release Test & In Vitro-In Vivo Correlation of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS .  FDA/CRCG Free Public Workshop: In Vitro Release Test & In Vitro-In Vivo Correlation of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products Don't miss the FDA and the Center for Research on Complex Generics public workshop, In Vitro Release Test and In Vitro-In Vivo Correlation of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products on June 29, 2022. This workshop is FREE. New! Full Agenda is now available. Register Now The purpose of this workshop is to discuss the scientific principles and practical considerations that inform current FDA thinking for IVRT and IVIVC studies to support the development and approval of complex generic ophthalmic, injectable, implantable, and inserted drug products. The workshop will provide an update on the progress of Generic Drug User Fee Amendments (GDUFA)-funded research activities, explore challenging issues that would benefit from a broader discussion, identify areas that need further research, and discuss opportunities for coordination and collaboration between FDA, generic industry, academic institutions, dissolution equipment manufacturers, contract research organizations, and consultants. TOPICS IVRT study design considerations for supporting bioequivalence and product quality, when applicable, for complex generic ophthalmic products including emulsions, suspensions, ointments, and implants IVRT study designs for supporting a demonstration of bioequivalence and as part of quality control for complex generic injectable products including suspensions, polymeric microspheres, in situ forming gels/implants, as well as implantable products including solid implants including intrauterine systems and intravaginal systems Novel IVRT methods for supporting generic product development and/or bioequivalence demonstration Theoretical principles and practical challenges of IVRT and IVIVC method development, validation, and transfer Submission of IVRT information in Abbreviated New Drug Applications, including format of data/results, organization of information, and common deficiencies. For more information about this workshop please visit, https://complexgenerics.org/IVRT-IVIVC/. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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