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FDA Urges Full Participation In Quality Metrics Program

 
• By Joanne S. Eglovitch

Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.

Pharmaceutical companies should participate in FDA’s quality metrics program and submit metrics data once an electronic portal goes live Jan. 1, 2018, Ashley Boam, acting director for the FDA’s Office of Policy for Pharmaceutical Quality, said Feb. 22 at the Parenteral Drug Association’s meeting on quality metrics and quality culture in Bethesda Md.

Without participation, the program will not succeed, as FDA will not have enough information to predict drug shortages and the industry will not see regulatory relief, Boam said.

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