John, are you there? [Tips / Tricks]

posted by jag009  – NJ, 2013-05-28 19:12  – Posting: # 10678
Views: 10,486

Hi Helmut!

We in US had Monday as a holiday you know. Yeah it's Tuesday and I am still on holiday mood... :party:

I "think" guidance is not cast in stone and you can present alternatives to FDA as long as you can justify them, even if it's the finalized guidance.

Guideline is cast in stone.

There are guidelines on FDA website. Example, Drug Master File Guideline

Regarding draft BA/BE guidances... Pretty much all the people I know treat the draft as final. In fact if you look at FDA's BE recommendations for specific drug products (The document which indicate the types of BE studies to be conducted), I think majority of them (I looked at some as far back as 2008) are still in draft.

Thanks
John

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,567 posts in 4,150 threads, 1,340 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 21:20 UTC

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5