The public meeting and draft guidance are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the authority of section 704 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance includes an explanation of CDER and CBER approaches to collecting and using data to aid in ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and that they support continuous improvement and innovation in the pharmaceutical manufacturing industry. The program is intended to play an important role in 1) fulfilling section 510(h)(3) of the Act, which requires FDA to inspect drug establishments in accordance with a risk-based schedule; and 20 attempting to predict and potentially mitigate drug shortages. The input from this public meeting will help inform potential revision of the draft guidance and the planned implementation of this program by FDA.
When & Where
United States Food And Drug Administration
Althea Cuff, Regulatory Project Manager