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As lawmakers and the FDA mull over proposals to address recent drug safety concerns, pharmaceutical firms are hoping that any potential fix will not focus on the premarket side of the equation, according to a top FDA official
NIH announced a new supplemental ethics regulation Feb. 1 that essentially bans its employees from collaborating with the pharmaceutical and biotechnology industries.
Federal regulators are preparing to conduct much more thorough examinations of drug products as part of an evidence-based approach to medicine that will drive the implementation of the Medicare Rx benefit, which is slated to take effect next year.
The recent safety concerns involving pharmaceutical products are beginning to have an effect on the American public’s perception of drug companies, according to a recent online poll.
The FDA’s inability to evolve and keep pace with the rapidly advancing pharmaceutical industry has left it with a wide array of problems, particularly on the drug safety front, asserts Eve Slater, former assistant secretary for health at HHS.
Statin developers received positive news on the research front last week in the form of two clinical studies that indicate statin drugs help reduce the body’s level of c-reactive protein (CRP), which has been associated with increased risks of coronary disease.
Eli Lilly has launched an online, publicly accessible registry on which it will post the results from all Phase I through Phase IV clinical trials for its marketed drug products.
The FDA's current safety monitoring system for marketed drugs is flawed because drugmakers are largely responsible for collecting, evaluating and reporting postmarketing data about their own products, according to an influential medical association that contends the existing system lacks vigilance and trust.