The public meeting and draft guidance are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the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 2) 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 The input from this public meeting will help inform potential revision of the draft guidance and the planned implementation of this program by FDA.
August 24, 2015
8:30 a.m. – 5:00 p.m.
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503B/C (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus)
Registration to Attend the Workshop
Recordings of Meeting:
Other Meeting Information
- Draft Guidance for Industry; Request for Quality Metrics (PDF - 250KB)
- List of FDA Panelists; Request for Quality Metrics (PDF - 32KB)
- Agenda; Request for Quality Metrics (PDF - 110KB)
- Quality Metrics Overview, Ashley Boam, MSBE, Acting Director, Office of Policy and Pharmaceutical Quality, FDA/CDER (PDF - 98KB)
- Request for Quality Metrics: Technical Specifications, Ron Fitzmartin, PhD, MBA, Senior Advisor, Office of Strategic Programs, FDA/CDER (PDF - 542KB)
- ISPE Comments, Diane Hagerty, Vice President, Genentech Inc. (PDF - 57KB)
FDA Request for Quality Metrics, John S. Punzi, Ph.D., Director, Quality Assurance and Technical Affairs, Consumer Healthcare Products Association (CHPA)(PDF - 186KB) PDA’s Quality Metric Public Meeting Comments, R.M. Johnson, President, Parenteral Drug Association (PDA)(PDF - 769KB) Quality Metrics Public Meeting, David R. Gaugh, R.Ph., Senior Vice President for Sciences and Regulatory Affairs, Generic Pharmaceutical Association (GPhA)(PDF - 337KB) IPEC-Americas Verbal Comments for Quality Metrics Guidance Public Meeting, Priscilla Zawislak, International Pharmaceutical Excipients Council (IPEC)(PDF - 80KB) FDA Public Meeting: Request for Quality Metrics, Alan W. Nicholls, Chair, Bulk Pharmaceuticals Task Force (BPTF)(PDF - 150KB)