OB Annual edition, Current Cumulative Supplement [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-07-19 16:24 (639 d 23:00 ago) – Posting: # 20405
Views: 1,894

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:


Dif-tor heh smusma 🖖
Helmut Schütz

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

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Monday 15:25 UTC (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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