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Faced with a barrage of international news stories, Aventis said last week it would file a report with the FDA about the deaths of five Japanese patients participating in a postmarketing study of its rheumatoid arthritis drug Arava, although the company contends there is no clear evidence the drug caused the fatalities.
Devicemakers could benefit if FDA Commissioner Mark McClellan leaves the agency and takes over as head of the Centers for Medicare & Medicaid Services (CMS) because of his intimate knowledge of the industry, according to AdvaMed.
Devicemakers undergoing a preapproval inspection should form a team that includes a coordinator, runners, scribes and subject experts to ensure that FDA inspectors’ needs are being met and that the scope of the inspection does not go beyond the agency’s authority.
Devicemakers need to provide the FDA with statistics to back up the number of process validation runs they choose to do on products under review to prove that the number was appropriate, according to an FDA official.
Representatives of drug manufacturers who were acting members on the Center for Drug Evaluation and Research's (CDER's) advisory committees will be made permanent, but still nonvoting, within three to six months, according to Igor Cerny, acting director of the CDER's advisory committee group.
While one group of U.S. researchers recently released a report finding that antidepressants like Prozac, Zoloft and Paxil do not raise the risk of suicide in children, other researchers claimed last week that drug companies’ refusal to release details of negative studies denies physicians and parents critical information needed to assess the safety of such drugs.