date:May 11, 2012
ailure to maintain adequate records.
NDIs
On the topic of the NDI draft guidance, Dr Fabricant reiterated that the agency is not preparing to enforce the draft guidance.
He recalled a presentation he gave last year where... the big issue on the table was the NDI draft guidance. I'm sure for many of you it still is. And it is just a draft guidance. I think everyone's heard me say that a million times, and we'll make it a million and one: It's just a draft guidance.
GMPs (are) the biggest chal