Need to know or nice to know [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-18 16:36 (1898 d 13:04 ago) – Posting: # 18214
Views: 1,462

Hi nobody,

THX for this goody! Read it in conjunction with the “Good Abbreviated New Drug Application Assessment Practices”. Very funny in section 1.A.:
  • […] Information that is scientifically or academically interesting but is not needed to make a regulatory decision is not relevant. In other words, primary assessors should focus on issues in their specific discipline that are need to know and not nice to know.
Seemingly there is a dinosaur at the FDA still remembering the motto of the BioInternational ’94 in Munich. ;-)

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

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

Complete thread:

UA Flag
 Admin contact
22,559 posts in 4,725 threads, 1,607 registered users;
15 visitors (0 registered, 15 guests [including 9 identified bots]).
Forum time: 06:40 CEST (Europe/Vienna)

The penalty for scientific irrelevance is, of course,
that the statistician’s work is ignored by the scientific community.    George E.P. Box

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