Blog / Government Affairs & Legislative / Regulatory Affairs
MDUFA V Agreement Enables Bold MedTech Vision to Become Reality
April 12, 2022
Congress is considering the latest agreement between the FDA and the industry to help fund agency consideration of medical devices with user fees.
News / Regulatory Affairs
AdvaMed Welcomes Opportunity to Testify on Historic Medical Device User Fee Agreement
March 29, 2022
AdvaMed welcomes the opportunity to testify before a key congressional committee on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA).
News / Regulatory Affairs
AdvaMed Statement on the FDA’s Draft Commitment Letter on the Medical Device User Fee Amendments V Agreement
March 23, 2022
The Food and Drug Administration (FDA) has released its draft commitment letter on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA), reflecting an agreement between the agency and the medical technology device industry. The agreement is now ready for public and congressional consideration.
Event / Regulatory Affairs / Small Business
The Innovation Roadmap™ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment
March 24, 2022
Event / Regulatory Affairs
14th Annual FDA/AdvaMed Medical Device Statistical Issues Conference
May 11, 2022 – May 13, 2022
This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations.
News / Government Affairs & Legislative / Regulatory Affairs
AdvaMed Statement on Confirmation of Dr. Califf to Lead FDA
February 15, 2022
Today, the Advanced Medical Technology Association (AdvaMed), the world’s largest trade organization representing medical technology manufacturers, released the following statements from President and CEO Scott Whitaker and Chairman of the AdvaMed Board of Directors Mike Minogue upon the confirmation of Dr. Robert Califf by the Senate as Commissioner of the Food and Drug Administration:
Resource / Digital Health / Global & Trade / Legal & Compliance / Regulatory Affairs / Small Business
Trendspotting 2022: On the Pulse of Life Sciences
January 31, 2022
Sidley’s Global Life Sciences group looks at 12 forces driving the life sciences legal and regulatory landscape in 2022, and provides practical tips on a range of topics for life sciences companies and investors seeking to navigatte through, and capitalize on, this complex environment.
News / Global & Trade / Regulatory Affairs
B. Braun Receives FDA Approval of Daytona Beach Pharmaceutical Manufacturing Site
January 28, 2022
Hyalex Orthopaedics, a privately-held medical device company developing transformational cartilage biomimetic products, today announced the appointment of Carl Vause as its new chief executive officer and president.