FDA draft BMV guidance revision published [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-09-12 18:22 (4668 d 01:45 ago) – Posting: # 11487
Views: 3,744

Dear Ohlbe,

THX!

❝ […] for a 90-day consultation period.


Wow, that’s an improvement. Still requiring recovery (what for?). At least they have managed to copypaste carryover from EMA’s GL. ;-) 7% ISRs, why not. Suggesting to run even a pilot study – not a bad idea.

Comments until 12 December 2013 to www.regulations.gov (see also “Tips for Submitting Effective Comments”).

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