X hits on this document

535 views

0 shares

0 downloads

0 comments

111 / 170

13

payment of your travel, lodging or other expenses in connection with your attendance at

14

the meeting. Likewise, FDA encourages you at the beginning of your statement to advise

15

the committee if you do not have any such financial relationships. If you choose not to

16

address this issue of financial relationship at the beginning of your statement it will not

17

preclude you from speaking.

4

beginning of the OPH session. As an announcement, both the FDA and the public

5

believe in a transparent process for information gathering and decision-making. To

6

ensure such transparency at the Open Public Hearing Session of the advisory committee

7

meeting, the FDA believes that it is important to understand the context of an individual’s

8

presentation. For this reason FDA encourages you, the Open Public Hearing speaker, at

9

the beginning of your written or oral statement to advise the committee of any financial

10

relationships that you may have with the Sponsor, its product, and if known, its direct

11

competitors.

19

hearing process. The insights and comments provided can help the Agency and this

20

committee in their consideration of the issues before them. That said, in many instances

21

and for many topics there will be a variety of opinions. One of our goals today is for this

22

Open Public Hearing to be conducted in a fair and open manner where every participant

23

is listened to carefully and treated with dignity, courtesy, and respect. Therefore, please

24

only speak when recognized by the Chair. Thank you for your cooperation.

12

For example, this financial information may include the Sponsor’s

110

18

The FDA and the committee place great importance in the open public

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

1

2

3

(Lunch recess.)

OPEN PUBLIC HEARING SESSION

DR. BURMAN: Good afternoon. We are now going to proceed to the

Document info
Document views535
Page views535
Page last viewedSat Dec 10 11:54:09 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments