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Back to the forum  2018-07-23 00:02 CEST (UTC+2h)

Different sources of Prescribing Information [Regulatives / Guidelines]

posted by Siddheshwar Shinde - India, 2018-03-21 11:07  - Posting: # 18575
Views: 1,040

Two different sources available for Prescribing Information (PI).
1. Drugs@FDA: FDA Approved Drug Products
2. DAILYMED (U.S. National Library of Medicine)

Drugs@FDA has last approved PI and posted by the Food and Drug Administration (FDA) itself.
The drug labeling information on DAILYMED is the most recent PI (different than FDA approved labeling) submitted (by firms) to FDA but labeling changes have not been approved by FDA.

Among these sources, which source of Prescribing Information being used during conduct of clinical study considering the safety and other concerns.

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