Wednesday, October 19, 2016

Important Things To Know Before The FDA Meeting For EPP On MONDAY

Important Things To Know Before The FDA Meeting For EPP On MONDAY

The FDA Meeting for EPP is just around the corner! The FDA has distributed additional information for all registered attendees. The check in process is lengthy, so everyone needs to be sure to arrive to the FDA at 9AM on Monday, October 24th. As a reminder, the APF will have a shuttle bus available to transport attendees between the Holiday Inn – College Park and the FDA.
Transportation: If you are taking a cab, ask the driver to drop you off at Building 1. If you will be driving and need to park, there will be signs labeled “Event Parking” pointing you in the direction of various surface parking lots (Southeast, 132A and 132B). Parking spots may be difficult to secure that will be close to Building 1, but there will be shuttles circulating to all parking lot bus stops every 5 minutes that can pick you up. Make sure to tell the shuttle driver to drop you off at Building 1. Here is FDA’s transportation page for more information:
http://www.fda.gov/…/WhiteOakCampusInformation/ucm241740.htm
Arriving: Please make sure to first arrive at Building 1 in order to clear security and enter FDA as a guest. Building 1 is the first building you see when you arrive on campus, behind the circle with flags. You will need to present a government issued ID. Once in Building 1, visitors will have to go through the x-ray and magnetometer machines and then go down a corridor to the Building 31 Great Room. The meeting will be taking place here in the “Great Room,” or Rooms 1503 B and C. There is a small portion of the path between Building 1 and 31 where visitors will be outside. There are stairs and a ramp between the buildings. We will have FDA staff helping direct visitors to the meeting room.
Registration: Please plan to arrive between 9:00-9:45am. We will have sign-in sheets available on the tables inside the room. Luggage can be kept in the meeting room, either with the individual or in the back of the room. Sara and Meghana will both be in the room to help you with anything else you might need. If you have any difficulties finding the meeting room, or if there are any immediate questions you may need to ask, Meghana’s cell phone number is 772-342-1816, and Sara’s is 412-606-9445.
Lunch: There is a kiosk in the foyer of the meeting room where food and beverages are available for purchase. You can pre-order your lunch in the morning before the start of the workshop; if you choose to pre-order, your lunch will be available for pick-up inside the meeting room itself (where we are planning to keep the lights dimmed) during the lunch break.
Example of Past Meetings: We have conducted meetings similar to this one in the past. Please find a link to a similar meeting we held for psoriasis here: http://www.fda.gov/…/…/PrescriptionDrugUserFee/ucm470608.htm. Here you will find the webcast recording and full transcript of the meeting.
Agenda: The workshop agenda is now available on the workshop webpage: http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm.
The patient panel will kick off the discussion in the morning, and will be followed by a large-facilitated discussion with patients and caregivers from the audience. So we encourage you to share your experience during the large-facilitated discussion portion of the workshop. The workshop is in-tended to be an opportunity for FDA to hear directly from patients, and we make every effort to make sure the voice of the patient is heard.
We also encourage you to submit your comments directly to our “public docket”. This is a website through which patients living with EPP and oth-ers can share their experiences and perspectives. These comments supple-ment the input we get from the workshop. We will review all of these com-ments. To submit your comment, visit:
https://www.regulations.gov/document?D=FDA-2016-N-1493-0001. Click on the “Comment Now” button in the top-right corner. You will be able to upload a PDF or Word version of your comments.
If you have any questions, you can contact the FDA at megha-na.chalasani@fda.hhs.gov. We are all looking forward to this workshop!

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