FDA committee to discuss ophthalmic drug marketing

Silver Spring, MD-Does marketing one bottle of anti-inflammatory ophthalmic product for use in both eyes for post-surgical indications have an effect on the potential risk for infection? The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will address this issue when it meets Feb. 27 from 9 a.m. to 3 p.m. at the DoubleTree by Hilton Hotel Washington DC – Silver Spring, 8727 Colesville Rd., Silver Spring, MD.

The agency’s Center for Drug Evaluation and Research is seeking advice from the committee “on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.”

Background material has been posted on the committee’s Web site; go to www.fda.gov/AdvisoryCommittees/Calendar/ucm280521.htm. Public comments will be accepted at the meeting from about 11:30 a.m. to 12:30 p.m.

The FDA also has opened a docket, number FDA-2011-N-0805, for public comment on this meeting through March 5. Those interested in commenting may submit information electronically at www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should include the docket number and will be posted without change, including any personal information provided, according to the agency.

Those interested may view comments weekdays in the FDA’s Division of Dockets Management between 9 a.m. and 4 p.m. at the aforementioned Rockville address.

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