February 27, 2012: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement
CANCELLED TOPIC 1; TOPIC 2 TO TAKE PLACE AS PREVIOUSLY ANNOUNCED. February 27, 2012: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement
UPDATED INFORMATION (as of 2/12/2012):
The portion of the meeting relating to the appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery (topic 1) has been CANCELLED.
The portion of the meeting relating to the appropriateness of marketing a single bottle of anti-inflammatory ophthalmic products for use in both eyes for post-surgical indications as it relates to the potential risk for infection (topic 2) will go forward as scheduled.
In summary, the following updates are being made for the February 27th Dermatologic and Ophthalmic Drugs Advisory Committee meeting:
The time is updated to read: “9:00 a.m. to 3:00 p.m.”
The agenda is updated to read as follows: “The committee will be asked to comment on the appropriateness of marketing a single bottle of anti-inflammatory ophthalmic products for use in both eyes for post-surgical indications as it relates to the potential risk for infection. The FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.”
Public Participation Information:
The sentence “Oral presentations from the public will be scheduled between approximately 11 a.m. to 12 noon” is updated to read “Oral presentations from the public will be scheduled between approximately 11:30 a.m. to 12:30 p.m.”
|CDER||February 27, 2012||9:00 a.m. to 5:00 p.m.||Hilton Washington DC/Silver Spring |
(scheduled to be renamed in January 2012 to DoubleTree by Hilton Hotel Washington DC/Silver Spring)
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Silver Spring, Maryland
The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): 1) appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of post-operative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and 2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for post-surgical indications as it relates to the potential risk for infection. The FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- FDA is opening a docket for public comment on this meeting. The docket number is FDA-2011-N-0805. The docket will open for public comment on November 17, 2011. The docket will close on March 5, 2012. Interested persons may submit electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments received will be posted without change, including any personal information provided. Submit a single copy of electronic comments or a paper copy of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this meeting notice. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Comments received on or before February 10, 2012, will be provided to the committee before the meeting.
- Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 2, 2012.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 3, 2012.
CDER will not be providing a webcast of the February 27, 2012 Dermatologic and Ophthalmic Drugs Advisory Committee meeting.
- Yvette Waples, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
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Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Yvette Waples at (301) 796-9001 at least 7 days in advance of the meeting.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).