SBIA: Register for Common Labeling Deficiencies and Tips for Generic Drug Applications Live Webinar

FDA | CDER | Small Business and Industry Assistance WEBINARS Common Labeling Deficiencies and Tips for Generic Drug Applications May 7, 2021 | 1:00 - 2:00 p.m. Eastern This webinar is FREE. Registration and Agenda this webinar FDA will discuss the most common labeling mistakes found in generic drug applications (Abbreviated New Drug Applications, or ANDAs), how to avoid them, and other labeling tips when submitting a generic drug application to the Agency. FDA will also provide answers to common labeling questions asked by generic drug applicants.  LEARNING OBJECTIVES Provide answers to commonly asked labeling questions by generic drug applicants Discuss common labeling deficiencies and how to fix them AUDIENCE Generic drug industry stakeholders, including current and potential applicants, who are interested in submitting an Abbreviated New Drug Application for generic drug development. 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

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