Bioequivalence and Bioavailability Forum

nobody nothing 2018-01-18 16:11 (2288 d 21:39 ago) Posting: # 18210 Views: 2,075	FDA Good ANDA submission practices Jan-2018 draft [Regulatives / Guidelines] Post reply
	Hi! https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm591134.pdf Whole Section "VI BE deficiencies" — Kindest regards, nobody

Helmut
★★★

Vienna, Austria,
2018-01-18 16:36
(2288 d 21:14 ago)

@ nobody
Posting: # 18214
Views: 1,619

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!
Helmut Schütz

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