Bioequivalence and Bioavailability Forum

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

posted by luvblooms  – India, 2019-07-19 14:29 (1973 d 02:10 ago) – Posting: # 20398
Views: 3,143

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




Hope that they have mentioned RS approval date there

Complete thread:

• FDA: Date when a product is designated as RS (or RLD) jag009 2019-07-18 19:11 [Regulatives / Guidelines] 
  • FDA: Date when a product is designated as RS (or RLD)luvblooms 2019-07-19 12:29
    • OB Annual edition, Current Cumulative Supplement Helmut 2019-07-19 18:24
      • OB Annual edition, Current Cumulative Supplement jag009 2019-07-22 04:16