The appropriate conditions will depend on the drug, but may include considerations regarding temperature, humidity, and exposure to light. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. April guidance: Comments regarding the draft document should be submitted within 60 days of publication. Regulatory Convergence Join the brightest minds in regulatory at the annual Regulatory Convergence. With an increased demand for the repackaging of solid oral dosage form drugs into unit-dose containers, the US Food and Drug Administration FDA on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.
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Based on stability data provided by Pfizer and reviewed by FDA, the tables of specific lots with extended use dates have been updated for the following products:.
U.S. Food and Drug Administration
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