X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 26 / 263

510 views

0 shares

0 downloads

0 comments

26 / 263

1

observations are grounded in good science.

Also, the warning letter process is being looked at.  We're launching a program to identify any inconsistency across program areas with respect to all drug cGMP letters.  It varies now from center to center whether the warning letters, when they go out to industry, are reviewed in the centers and this is what we're working towards, is consistency along that line and planning that those warning letters will be reviewed in the centers before they go out.  They'll be reviewed to ensure that the science is strong science, that it's built into the warning letters.

Manufacturing science.  This is a very important thing.  This is part of ensuring the efficiency and quality of pharmaceutical manufacturing and associated regulatory processes.  We want to facilitate, as I said earlier, the introduction of modern manufacturing technologies and systems.  We also want to, though, be able to enhance FDA's expertise into pharmaceutical engineering and technologies.  We ourselves admit that we need to strengthen here some of our knowledge to be able to better understand in some cases what constitutes really

Document info
Document views510
Page views510
Page last viewedSat Dec 03 10:37:58 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments