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Given the technical, financial and regulatory hurdles of adopting erecord security programs, it is perhaps no surprise that many FDA regulated life sciences firms have been wary of moving aggressively into this area.
The FDA is considering using academic research into the way people process information to redesign the agency’s website and improve its delivery of drug safety information to consumers, according to FDA officials.
The FDA has granted priority review status to Elan and Biogen Idec’s supplemental biologics license application (sBLA) for Tysbari, clearing the way for the agency to issue a decision on the drug by late March 2006.
Both low- and high-dose versions of Somerset Pharmaceuticals’ experimental antidepressant patch should carry a warning that alerts patients not to consume certain foods while using the drug, according to briefing documents released in advance of an FDA advisory committee meeting.
Biogen Idec and Elan have reported more positive news about their withdrawn multiple sclerosis (MS) drug Tysabri, announcing Oct. 17 that a safety analysis found no new cases of a rare brain disease among patients who took the drug to treat rheumatoid arthritis and Crohn’s disease.
Pfizer and sanofi-aventis received more positive news last week on their highly anticipated inhaled insulin drug Exubera when a European Medicines Agency (EMEA) advisory committee recommended approval of the product for Type 1 and 2 diabetes.
The Center for Drug Evaluation and Research's (CDER) risk communication strategy for human drugs will be the topic of a two-day public hearing in early December that will focus on collecting public feedback on the effectiveness of the center's communication activities.
The FDA has signed five-year cooperative research contracts with four organizations through which the agency will continue to conduct postmarketing research via several massive patient databases.
Roche’s acne drug Accutane will soon be more difficult to obtain following the FDA’s approval of a stricter distribution program intended to further limit safety risks associated with the drug.