Nonbinding Recommendations [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2014-06-25 14:42 (4388 d 23:19 ago) – Posting: # 13141
Views: 1,814

Hi Bharathnadh,

❝ while i preparing the protocol based on US-FDA gudelines i refered Nonbinding Recommendations (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm). but methazolamide not having Nonbinding Recommendations. i cant understand right now please suggest me.


All of FDA’s recommendations are nonbinding. If you want to deviate, see this post (i.e., don’t sub­mit such a study without controlled correspondence). If a drug is not listed in the product-specific guidances, the general ones are still applicable.

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

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
251 visitors (0 registered, 251 guests [including 16 identified bots]).
Forum time: 14:02 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

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