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The FDA will conduct two studies to investigate how the context and format of risk information in direct-to-consumer (DTC) print advertisements influence consumers’ understanding of drug risks.
The FDA has recommended that manufacturers of sleep agents initiate clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports, the agency said.
Some courts are placing drug companies in an impossible situation by failing to recognize the FDA’s preemption authority in product labeling cases, the Washington Legal Foundation (WLF) said.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
The U.S. Food and Drug Administration (FDA) is exempting drugs that will be used for the President’s Emergency Plan for AIDS Relief (PEPFAR) from Prescription Drug User Fee Act fees to lessen the financial difficulties associated with developing the products, agency guidance says.
The U.S. Food and Drug Administration (FDA) has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
The FDA needs to strengthen its regulation of direct-to-consumer (DTC) advertising after the agency took more than six months to cite a drugmaker for advertisements suggesting a sleep aid was indicated for use in children, Consumers Union said.
The FDA has recommended that manufactures of sleep agents initiate clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports, the agency said March 14.
A bipartisan group of lawmakers is using a recent government report to pressure the Bush administration to increase funding for FDA oversight of direct-to-consumer (DTC) drug advertising and to institute a moratorium on ads for newly approved products.