FDA: Date when a product is designated as RS (or RLD) [Regulatives / Guidelines]

posted by luvblooms  – India, 2019-07-19 12:29  – Posting: # 20398
Views: 906

Hi John


» Does anyone know if there is a way to find out when FDA assigns a product as an RS (or RLD)? I mean the date, at least month and year?


I think it is available in printed version of Orange Book.

Got this from this presentation which says that in the printed version of the Orange Book, the reference standard selected by FDA for a drug product will be identified by the “!” symbol.


And the said line is followed by this image

[image]


Hope that they have mentioned RS approval date there

~A happy Soul~

Complete thread:

Activity
 Admin contact
20,134 posts in 4,245 threads, 1,385 registered users;
online 17 (0 registered, 17 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 01:41 CET

A Camel is a Horse designed by committee.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5