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Results from a recent open-label study showed that Pfizer's antibiotic Zyvox increased the risk of death in patients with Gram-negative, catheter-related infections, according to an FDA MedWatch report issued March 16.
Moving to minimize the effect of generic competition for its blockbuster hypertension drug, Pfizer plans to authorize the sale of its own generic Norvasc, the company announced last week.
Language in newly signed free trade agreements covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of lawmakers contends.
FDA Commissioner Andrew von Eschenbach's establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a "nice" idea but is not necessary for accomplishing the FDA's mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
The FDA has sent Congress its final recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), including an increase in user fees to pay for drug safety reviews as well as reviews of direct-to-consumer (DTC) advertising.
The FDA is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form data in extensible markup language based on the operational data model developed by the Clinical Data Interchange Standards Consortium.
HHS Secretary Michael Leavitt is calling for a new healthcare system in the U.S. modeled after the Medicare Part D drug benefit and based on competition and quality standards.
In his latest appearance before a congressional committee, FDA Commissioner Andrew von Eschenbach once again defended the agency's approval of the controversial antibiotic Ketek.