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If a drug becomes scheduled, how long does LARA have to notify?

User Hiepnd
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Final answer:

LARA must notify relevant parties promptly when a drug becomes scheduled, although the exact timeline may vary. Reporting to the FDA for adverse drug events by the sponsor is required within 15 days for serious events, and quarterly for others.

Step-by-step explanation:

When a drug becomes scheduled, the Licensing and Regulatory Affairs Agency (LARA) is responsible for promptly notifying the necessary parties. The timeframe for this notification can vary depending on specific regulations and schedules of controlled substances. In the context of adverse drug experiences, the sponsor must report unexpected serious and fatal adverse events to the FDA within 15 days, and less serious events on a quarterly basis according to Libre Texts. While LARA's specific timelines for notification about scheduling drugs are not detailed here, the context suggests that regulatory agencies have responsibilities to report within defined timeframes after certain events, such as adverse drug reactions.

User Tamakisquare
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