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jag009 ★★★ NJ, 2019-07-18 19:11 (795 d 21:12 ago) Posting: # 20393 Views: 2,724 |
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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 |
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luvblooms ★★ India, 2019-07-19 12:29 (795 d 03:54 ago) @ jag009 Posting: # 20398 Views: 2,038 |
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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]](img/uploaded/image163.jpg) Hope that they have mentioned RS approval date there — ~A happy Soul~ |
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Helmut ★★★   Vienna, Austria, 2019-07-19 18:24 (794 d 21:59 ago) @ luvblooms Posting: # 20405 Views: 2,021 |
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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]](https://forum.bebac.at/img/uploaded/image609.png) — Dif-tor heh smusma 🖖 Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2019-07-22 04:16 (792 d 12:06 ago) @ Helmut Posting: # 20420 Views: 1,945 |
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Thanks guys. Unfortunately the documents don't post the date when the drug becomes a RS. Thanks for your help,as always. John |
Ing. Helmut Schütz