jag009
★★★

NJ,
2019-07-18 19:11
(1118 d 12:06 ago)

Posting: # 20393
Views: 2,875
 

 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 12:29
(1117 d 18:48 ago)

@ jag009
Posting: # 20398
Views: 2,189
 

 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
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Vienna, Austria,
2019-07-19 18:24
(1117 d 12:53 ago)

@ luvblooms
Posting: # 20405
Views: 2,153
 

 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 🖖 [image]
Helmut Schütz
[image]

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jag009
★★★

NJ,
2019-07-22 04:16
(1115 d 03:00 ago)

@ Helmut
Posting: # 20420
Views: 2,075
 

 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
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