FDA Issues Proposed Rule for Early Notification of Essential Drug Supply Changes

The Food and Drug Administration has released a proposed rule that would require manufacturers of several vital prescription drugs to notify the FDA upon manufacturing interruptions or discontinuations likely to affect drug supply, according to a report from AHA News Now.

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The rule also extends to medically important biologic products.

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In conjunction with the proposed rule, the FDA has sent Congress a plan for improving the FDA’s ability to react in response to drug shortages.

The FDA will accept comments on the rule until Jan. 3, and comments on the information collection requirements until Dec. 4.

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