jag009
★★★

NJ,
2019-07-18 21:11
(1714 d 14:14 ago)

Posting: # 20393
Views: 3,201
 

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

Hi,
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?

Thanks
John
luvblooms
★★  

India,
2019-07-19 14:29
(1713 d 20:56 ago)

@ jag009
Posting: # 20398
Views: 2,464
 

 FDA: Date when a product is designated as RS (or RLD)

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~
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-07-19 20:24
(1713 d 15:01 ago)

@ luvblooms
Posting: # 20405
Views: 2,430
 

 OB Annual edition, Current Cumulative Supplement

Hi Luv and John,

I can’t believe it that the FDA refers to the printed version in the 21st century…
Instead, use the Annual Edition (current is the 39th of Dec 31, 2018) and the Current Cumulative Supplement (of Jun 6, 2019). PDFs, where you can search for the RLD, check +!, and the date of approval. See the example given in the OB:

[image]

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
jag009
★★★

NJ,
2019-07-22 06:16
(1711 d 05:08 ago)

@ Helmut
Posting: # 20420
Views: 2,379
 

 OB Annual edition, Current Cumulative Supplement

Thanks guys.

Unfortunately the documents don't post the date when the drug becomes a RS. Thanks for your help,as always.

John
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,640 registered users;
76 visitors (0 registered, 76 guests [including 9 identified bots]).
Forum time: 10:25 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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