Save the Dates for 2024 FDA and CRCG Co-Sponsored Events on Complex Generic Product Topics

Save the Dates for 2024 FDA and CRCG Co-Sponsored Events on Complex Generic Product Topics https://www.complexgenerics.org/?utm_medium=email&utm_source=govdelivery The Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) – 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. One way to achieve this mission is through collaborative research, training, and exchange of resources between FDA, the generics industry, academic institutions and other groups interested in the development of complex generic products. Please mark your calendars and plan to join us for the following 2024 workshops. More information to come! Drug-Device Combination Products: Updates and Challenges in Demonstrating Generic Substitutability March 14-15, 2024 (in-person and virtual) The purpose of this two-day workshop is to share information with the generic drug industry that may inform drug-device combination product (DDCP) development and to provide a forum to identify and discuss generic DDCP development challenges and explore potential solutions. Insights from GDUFA-funded research results will be discussed, along with FDA guidance recommendations for generic DDCP development. Experts in device user interface assessment, human factors, biostatistics, device quality assessment, and device evaluation will review the current scientific thinking on these topics and contribute to discussions about how best to address challenges and overcome obstacles in the generic DDCP space. Considerations and Potential Regulatory Applications for a Model Master File May 2, 2024 (in-person and virtual) The purpose of this workshop is to engage stakeholders in a discussion on the concept, scope, and regulatory application of a Model Master File (MMF), a framework aimed at model-sharing and communication between model developers, industry and FDA. The workshop will discuss challenging aspects of MMF development and implementation. The main objective of the workshop is to facilitate the incorporation and efficient assessment of modeling and simulation evidence in regulatory submissions through coordination and collaboration between the FDA, new and generic drug developers, academic institutions, contract research organizations, consultants and others involved in drug product development. The information exchange and discussions during the workshop will allow for a shared understanding of the role of a MMF in advancing drug product development, enhancing regulatory consistency and efficiency, and streamlining drug product approval. Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products: Present State and Future Directions October 7-8, 2024 (in-person and virtual) The use of non-clinical comparative immunogenicity risk assessment for generic peptide and oligonucleotide drug products is gaining momentum as it may facilitate their approval without the need for costly studies. However, the implementation of such an approach requires that the associated assays be suitable for their intended purpose and reproducible. The workshop discussions will focus on recent advances in this field and the remaining hurdles that need to be addressed to help the field move forward in a manner that supports public health. Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products November 7, 2024 (in-person and virtual) The purpose of this workshop is to review the current research and recommendations on methods for confirmatory testing of NDSRI formation, safety testing methods for NDSRIs and recommended acceptable intake limits for NDSRIs based on predicted carcinogenic potency and compound-specific data or read-across analysis. The workshop will also discuss strategies to mitigate the risk of NDSRIs formation. Another key focus of the workshop is to provide an update on FDA policy and guidance in assessing formulation stability, and recommendations for bioequivalence approaches when drug developers are considering reformulation. Navigating the Transition to Low Global Warming Potential Propellants December 4-5, 2024 (in-person and virtual) The transition of metered dose inhaler (MDI) drug products from hydrofluoroalkane (HFA) propellants to new low global warming potential (LGWP) propellants raises potential scientific and regulatory challenges for both new drug and generic MDIs. This two-day workshop will engage subject matter experts from academia, new and generic drug industries, and the FDA to discuss the current status, challenges, development programs, manufacture, and regulatory considerations for both new and generic MDIs with LGWP propellants.