FDA to Probe NSAID's (Celebrex and Bextra)
The FDA announced Friday that it will hold three days of hearings in February on the benefits and risks of the COX-2 family of drugs. This includes Pfizer Inc.'s Celebrex and Bextra arthritis medications.
Kathleen Quinn, a spokeswoman for the FDA, said regulators would allow the public to comment, either orally, in writing or with data. Public comments would be allowed during the first day of the hearing between 1 and 3 p.m., but time would be limited.
Pfizer (Celebrex and Betra) officials have been asked to make presentations during the three-day hearing and will participate. They say they welcome the opportunity to be heard but haven't determined which officials will be making presentations.
What follows is the press release from the FDA web site:
FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs
The Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005.
The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.
Members of the public are encouraged to participate in this meeting. Interested persons may present data, information or views, orally or in writing, on issues pending before the committees. Oral presentations from the public will be scheduled between 1:00 p.m. and 3:00 p.m. on February 17. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should register to speak at the meeting before February 4, 2005. No registration is required for those only planning on attending the meeting.
The three-day meeting will be held at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Md. The proceedings will start at 8:00 a.m. each day. Agendas and other background materials will be posted online no later than one business day before the meeting.
For more information regarding this meeting, including contact information for members of the public interested in making presentations or submitting written comments please go to: http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html.
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posted by Wild Card @ 10:10 AM
5 comments
5 Comments:
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