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如题
Action
Notice of public meeting; request for comments.
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled “Patient-Focused Drug Development for Vitiligo.” The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors c**idered when selecting a treatment.
Dates
The public meeting will be held on March 30, 2020, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public meeting by June 1, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Addresses
The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer tohttps://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely filed comments will not be c**idered. Electronic comments must be submitted on or before June 1, 2020. Thehttps://www.regulati**.govelectronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 1, 2020. Comments received by mail/hand delivery/courier (for written/paper submissi**) will be c**idered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Electronic Submissi**
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulati**.gov.Follow the instructi** for submitting comments. Comments submitted electronically, including attachments, tohttps://www.regulati**.govwill be posted to the docket unchanged. Because your comment will be made public, you are solely resp**ible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted onhttps://www.regulati**.gov.If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissi**” and “Instructi**”).
Written/Paper Submissi**
Submit written/paper submissi** as follows:
Mail/Hand delivery/Courier (for written/paper submissi**):Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructi**.”
Instructi**:All submissi** received must include the Docket No. FDA-2020-N-0255 for “Patient-Focused Drug Development on Vitiligo; Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissi**,” publicly viewable athttps://www.regulati**.govor at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissi**—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its c**ideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted onhttps://www.regulati**.gov.Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket:For access to the docket to read background documents or the electronic and written/paper comments received, go tohttps://www.regulati**.govand insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For Further Information Contact
Shannon Cole, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-796-9208,PatientFocused@fda.hhs.gov.
Supplementary Information
I. Background
This meeting will provide FDA the opportunity to obtain patient and patient representative input on the aspects of vitiligo that matter most to patients, including how it affects daily life, and on current approaches to treating vitiligo. Vitiligo is an autoimmune disease that causes the loss of skin color. The loss of color can affect skin, hair, and other areas of the body. The area affected by color loss can range in individual patients from small discrete areas to near total involvement. Although there is no cure or FDA-approved treatment for repigmentation, there are available therapies, such as prescription medicati** or non-drug therapies, which may often be used to manage aspects of vitiligo. FDA is interested in patients' (including adult and pediatric patients) perspectives on: (1) The impact of their vitiligo; (2) treatment approaches; and (3) decision factors c**idered when selecting a treatment.
The questi** that will be asked of patients and patient representatives at the meeting are listed in the following section and organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This discussion will be followed by a facilitated discussion inviting comments from other patients and patient representatives. In addition to input generated through this public meeting, FDA is interested in receiving patient and patient representative input addressing these questi** through written comments, which can be submitted to the public docket (see ADDRESSES). When submitting comments, if you are commenting on behalf of a patient, please indicate that you are doing so and answer the following questi** as much as possible from the patient's perspective.
FDA will post the agenda and other meeting materials approximately 5 days before the meeting at:[url=https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-vitiligo-03302020-03302020.]h |
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发表于 2020-6-3 15:36:49
