FDA BRIEF: Week of June 20, 2016
FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science
By: Robert M. Califf, M.D., Commissioner
- FDA commitment to using best available science to support mission to protect and promote public health
- Scientific breakthroughs offer unprecedented opportunities to develop new treatments and cures
- Deep personal and professional satisfaction gained from working in FDA’s state-of-the-art laboratories on front-line issues
Being Part of a Vibrant Collaborative Scientific Environment
- FDA offers opportunity to be part of vibrant, collaborative culture of regulatory science
- Work is directly tied to regulatory decisions
- Fellowship, internship, graduate, and faculty programs
Tackling the Most Challenging Scientific Issues
- Encourages professionals collaborate with FDA on transformative scientific issues
- Need the best scientific minds to make science-based decisions on benefit/risk
- Great career opportunities at FDA
FDA Celebrates the 40th Anniversary of the Medical Device Amendments
by: Jeffrey Shuren, M.D., J.D., Director of CDRH
- FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments
- Congress gave FDA explicit authority over medical devices in the 1938- but focus only on fraudulent products
- Safety disaster with ‘Dalkon Shield’ enacted Medical Device Amendments in 1976 for risk based classification and GMP compliance
- Ushered in a new era for medical technology innovation, patient access, and patient safety – along with political tensions
- CDRH has adapted expertise and regulatory approaches to meet rapidly evolving innovation
- Digital Health regulatory framework
- National Evaluation System (NEST)
- Patient engagement