FDA Seeks Input on Manufacturing Quality ‘Metrics’ as Part of Shortages Strategy

The FDA is asking drugmakers to share their methods for measuring manufacturing quality and asks whether such “metrics” should be used to guide patients and prescribers in their product choices.

Such input is sought as part of a larger request for comment, set to be published in Tuesday’s Federal Register, on ways the agency intends to tackle the drug shortage crisis.

As required by the FDA Safety and Innovation Act, the FDA plans to establish a drug shortages task force to implement a regulatory roadmap for preventing and mitigating supply disruptions.

The law also provides for the creation of a “qualified manufacturing partner program.” Under such a program, certain drugmakers would be designated “qualified manufacturers” with “the capability and capacity to supply products determined or anticipated to be in shortage” quickly.

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