SBIA: Tomorrow's "FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs" Live Webinar

FDA | CDER | Small Business and Industry Assistance WEBINARS FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs TOMORROW - May 5, 2021 | 9:00 - 12:30 p.m. Eastern This webinar is FREE. Registration and Agenda This webinar 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 assessment. 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. AGENDA TOPICS Non-Complex Drug Products and Product-Specific Guidances Product-Specific Guidances for Complex Generic Drugs Product-Specific Guidance Fundamentals from a Clinical Perspective Developing and Implementing Science-Based Standards in Bioequivalence Assessment Bioequivalence Regulations and Product-Specific Guidances AUDIENCE Generic drug industry stakeholders, including generic drug applicants and prospective applicants who are interested in submitting an application for a generic drug.   This webinar is part of the SBIA Regulatory Education for Industry (REdI) series. This webinar is being offered as part of FDA's Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA's high standards for quality and scientific rigor. CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event. This course: has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion. has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant's RQAP re-registration. has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates 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

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA