FDA CDER's Upcoming Small Business and Industry Assistance Training

If your email program has trouble displaying this email, view as a webpage. May 3, 2021 Upcoming SBIA Training   Dear International Colleague, Please note the upcoming Free Small Business and Industry Assistance (SBIA) training offered by the Food and Drug Administrations Center for Drug Evaluation and Research: Find details and additional offerings on the SBIA Learn webpage. All webinars and conferences are FREE. May 5: FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs FDA will provide an overview of Product-Specific Guidances (PSGs), including how they are developed and revised and their role in facilitating generic drug development and generic drug application review. FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development. May 7: Common Labeling Deficiencies and Tips for Generic Drug Applications FDA will discuss the most common labeling mistakes found in Abbreviated New Drug Applications (ANDAs) and how to avoid them and other labeling tips. FDA will also provide answers to common labeling questions asked by generic drug applicants. May 14: FDA and Health Canada Regional ICH Consultation FDA and Health Canada will be co-hosting a regional public meeting to provide information and receive comments on current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) efforts and anticipated future topics. The public meeting will include discussion of harmonization guidelines reaching significant ICH milestones and other topical issues.  Issues to be discussed will include good clinical practice principles, lifecycle management, model-informed drug development, and patient-focused drug development.  Jun. 23: FY 2021 Generic Drug Science and Research Initiatives Public Workshop The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives.  Recent SBIA Recordings Posted Drug Master File (DMF) and Drug Substance Question and Answer Webinar following March 3-4, 2021 Workshop   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

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