Drug Shortages: FDA Wants Ideas To Boost Manufacturing Quality For Strategic Plan
This article was originally published in The Pink Sheet Daily
Agency asks for comments to help it formulate a strategic plan to mitigate and prevent drug shortages, including ideas for incentives to increase manufacturing capacity and promote increased quality.
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The Flucelvax flu vaccine is the first approved in the U.S. that is derived from cell-based technology instead of the traditional egg-based process. It will be made at Novartis’ Holly Springs, N.C. plant.
OGD Director Geba says generic manufacturers still suffer from extensive quality problems, but GPhA officials argue the industry is doing fine and communications with the agency need to be more uniform.