X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 19 / 263

610 views

0 shares

0 downloads

0 comments

19 / 263

1

advances in manufacturing and technology.  We often find, as Ajaz talked about yesterday, that we sometimes feel like the industry doesn't move forward in these areas because FDA is sort of standing in their way.  As Ajaz says, we don't want to be responsible for that.  We're really trying to encourage scientific advances.  So this is part of what we've built into the initiative.

We want to better integrate the review program with the inspection program which I've already mentioned.  It's a continuum across.

We want to ensure consistency in standards.  It's a very important part of how we do business and how industry and others do business.

And we want to encourage again innovation and focus resources effectively to address the most significant health risks that are out there.

Just to give you an overview of the initiative so you know what it entails, it basically applies to pharmaceuticals, biological human drugs, and veterinary drugs, and the focus is on the review, as I've already said, of drug product applications and the inspection of manufacturing facilities.  The initiative is being

Document info
Document views610
Page views610
Page last viewedWed Dec 07 11:14:24 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments