FDA publishes results of final assessment and announces virtual public meeting on Biosimilar User Fee Act’s (BsUFA) Program for Enhanced Review Transparency and Communication

On March 22, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting to discuss the final assessment of the Pro

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA publishes results of final assessment and announces virtual public meeting on Biosimilar User Fee Act's (BsUFA) Program for Enhanced Review Transparency and Communication   On March 22, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting to discuss the final assessment of the Program for Enhanced Review Transparency and Communication ("Program") in the Biosimilar User Fee Act of 2017 (BsUFA II). The goal of the Program is to promote the efficiency and effectiveness of the first-cycle review process and minimize the number of review cycles necessary for approval, ensuring that patients have timely access to safe, effective, and high-quality biosimilar and interchangeable biological products. This final assessment follows the interim assessment published in December 2020. This virtual public meeting will discuss the results of an independent contractor's final assessment of the Program (including anonymized and aggregated feedback from BLA applicants and FDA review teams), in addition to any issues identified within the program, and recommendations for improvement. The public meeting agenda will include presentation of the final assessment and perspectives from multiple stakeholders, as well as time allotted for public comment and discussion. Registration to attend this virtual public meeting is voluntary but will allow registrants to receive updates when new information or additional materials are available, and submit a request to make a verbal comment at the meeting. Attendees who wish to make a verbal public comment must submit a request by March 10, 2022. The meeting's agenda, additional materials, and any other updates will be posted to FDA's website as they become available. Information about how to submit comments to the public docket will also be added to the website once available.    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 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