Upcoming: Fireside Chat with Dr. Robert Califf
On Friday, January 20, the Alliance discussed food safety and nutrition with Commissioner Califf and Deputy Commissioner Woodcock. It was a productive meeting and reinforced the importance of the Alliance as an advocate for FDA and CFSAN funding. Our key talking points are this week’s Analysis and Commentary.
NEW! Alliance Fireside Chat with FDA Commissioner Robert Califf
Friday, February 10 2:30 to 3:30 pm. Register here.
February 10 is a year (less one week) from Dr. Califf’s 1-year anniversary as Commissioner. He has agreed to do a fireside chat with the Alliance to discuss his first year and his vision for the future for FDA.
Last year’s reauthorization of the user fee programs food safety, cell and gene therapy, cosmetics safety, and regulation of innovative products are likely be discussed. As well, we will want to hear about his progress in recruitment and retention of scientific staff and plans for investment in technology that will strengthen the agency.
FOR ALLIANCE MEMBERS ONLY. Please let us know what topics you would like Dr. Califf to address. We won’t be able to get to everything, but we do want to be sure we cover areas where there are strong Alliance member interest. Your comments should be sent to Steven at info@strengthenfda.org by Thursday, February 2.
Webinar on Diagnostics with Elizabeth Hillebrenner, CDRH Associate Director for Scientific and Regulatory Programs.
Wednesday, February 15 from 2:00 to 3:00 pm. Register here.
The diagnostics market has evolved in size and complexity but many diagnostic tests that patients receive do not undergo FDA review and clearance.
This educational webinar is intended to highlight FDA’s role in the current regulatory landscape for diagnostics and underscore why regulation in the diagnostics space remains so complicated. Attempts to pass legislation clarifying FDA’s statutory authority with respect to diagnostics fell short in the last session of Congress and the FDA has said it may consider using its rulemaking authority in this area.
The webinar will also cover topics such as increased staffing and resource needs for the agency if it is required to oversee a larger number of diagnostics in the future. The webinar will be at 2 p.m. on February 15. Register here.
Transcript Available from January 13 Webinar with Deputy Commissioner Fristedt. On January 13, 2023, the Alliance for a Stronger FDA held an informative webinar with Andi Fristedt, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs. She covered a wide range of issues including: the user fee actions taken by Congress last September; the additional authorities provided to FDA as part of the Consolidated Appropriations Act of 2023; priorities for the coming year; and anticipation f challenges facing the FY 2024 budget request.
Her remarks are summarized here. A transcript of the session is now available here.
Alliance FY 24 Budget Webinars Coming in March and April. After the February webinars, the Alliance will have a series of webinars in late March and early April on the President’s FY 24 budget request. There will be six programs in total—each focusing on a specific Center or the Office of Regulatory Affairs. Date/time and further program details should be announced soon.
Reminder to Alliance Members. On Monday, January 16, Alliance members received an online link to register approval/disapproval/abstention for a new slate of directors whose term will run through 2024. They will join others on the board whose terms run through 2023.
If you have not already responded, please follow this link for additional information and register your organization’s position here. We have a busy year ahead and your board members provide incredibly valuable insights and service.