US FDA - Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
- Date
- May 2, 2025
- Category
US Regulations
- Description
On 23 April 2025, FDA published a notice in the Federal Register indicating that the Agency is extending its voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program and outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program. See https://www.federalregister.gov/documents/2025/04/23/2025-06968/voluntary-quality-management-maturity-prototype-assessment-protocol-evaluation-program
It’s not clear what effect the recent reduction in workforce will have on the conduct of the QMM program, which relies heavily on contractors. The pilot program is being run by CDER’s Office of Pharmaceutical Quality