🔹 ABOUT THESE EVENTS 

• April 25, 2024, 1:00 PM - 4:00 PM ET
  Facilitating Generic Drug Product Development through Product-Specific Guidances
  
  If you are a current or prospective generic drug applicant, attend this webinar for insights into how Product-Specific Guidances (PSGs) are developed, revised, and published, and how PSGs may be used to improve the efficiency of generic drug development. The webinar will include a panel discussion on topics pertinent to PSGs and a live Q&A session with FDA experts.
  
  The webinar will cover: General principles of PSG, PSG lifecycle overview, utility of PSGs, and updates on the PSG program.
  
  Learn more and register today!
  
  
• May 9, 2024, 1:00 PM - 3:30 PM ET
  Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
  
  In this webinar, FDA will address how the redesigned scope and features of the pre-submission meeting may benefit preparation of an Abbreviated New Drug Application (ANDA) submission and its regulatory assessment post submission. The webinar will include a hypothetical case illustrating how to prepare a successful pre-submission meeting request, a panel discussion on topics pertinent to the generic drug industry, and a live Q&A session with FDA experts.
  
  The webinar will cover: An overview of scope and new features of pre-submission meetings under GDUFA III, the benefits of pre-submission meetings, how and when to utilize pre-submission meetings, and preparation of pre-submission meeting requests.
  
  Learn more and register today!

🔹 AND DON'T FORGET

• Explore our CDER SBIA Learn Online Training Repository, which contains guidance for all stages of pharmaceutical research, review, and manufacturing, now offers select Spanish-captioned pharmaceutical trainings for generic drug manufacturers. Feel free to share this resource with friends and colleagues.

🔹 INTENDED AUDIENCE

• Current and prospective applicants, consultants, regulatory affairs professionals, or contractors who are interested in submitting, are in the process of submitting, or have submitted ANDAs
• Regulatory reviewers for generic drug assessments, consultants focused on bioequivalence, clinical research coordinators, and regulatory affairs professionals