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FOOD AND DRUG ADMINISTRATION - page 31 / 263

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we hope to be able to do is to develop appropriate metrics and a mechanism for evaluating the entire initiative, so that two years from now, three years from now, four years from now, whatever, we can go back and look at how successful we have been in instituting the changes under the initiative.

Basically, next steps is we'll have a workshop in April to begin to vet a number of these initiatives, to get input from the stakeholders.  I think this is an important part of the overall initiative.  We'll also be vetting a number of the questions, scientific questions that come up in the area of manufacturing before the subcommittee and the advisory committee.  As I've said, I think you'll see a number of these issues in the next six months or so.

We're getting several draft guidances out to issue for public comment, including the one on comparable protocol and dispute resolution.  We'll definitely have additional workshops to focus on a number of the scientific issues under the initiative, probably even have another workshop before the year is over, and again we're in the process of clarifying part 11.

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