nobody
nothing

2018-01-18 16:11
(2261 d 16:33 ago)

Posting: # 18210
Views: 2,005
 

 FDA Good ANDA submission practices Jan-2018 draft [Regulatives / Guidelines]


Kindest regards, nobody
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2018-01-18 16:36
(2261 d 16:09 ago)

@ nobody
Posting: # 18214
Views: 1,562
 

 Need to know or nice to know

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
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
107 visitors (0 registered, 107 guests [including 2 identified bots]).
Forum time: 08:45 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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