Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-04-25 02:52 CEST (UTC+2h)
 

Different sources of Prescribing Information [Regulatives / Guidelines]

posted by Siddheshwar Shinde - India, 2018-03-21 11:07  - Posting: # 18575
Views: 844

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.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
18,208 posts in 3,871 threads, 1,154 registered users;
28 users online (0 registered, 28 guests).

Mediocrity finds safety in standardization.    Frederick E. Crane

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed