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A new drug to block the effects of nicotine may give smokers a better chance of beating the odds during their first three months of quitting in comparison to another treatment and placebo, according to three recent clinical trials.
The FDA believes that its ongoing efforts to improve postmarket drug reviews are sufficient to address perceived flaws in the agency’s procedures, a key agency official says.
When drug companies fail to submit postmarketing studies, the FDA needs to have the ability to impose financial penalties, said a public advocacy group.
A public advocacy group is calling on the FDA to impose financial penalties on companies that submit their annual postmarket study reports late, arguing that fines are necessary to ensure that results are issued on time.
The FDA needs to provide new incentives for the drug industry to speed the development of pharmaceuticals to treat infectious diseases in developing countries, say Duke University researchers.
The FDA needs the ability to impose financial penalties as an incentive for drug companies to submit required annual postmarket study reports on time, according to a public advocacy group.
The National Academies’ Institute of Medicine (IOM) will be holding its final drug safety meeting next week in preparation for a long-awaited report that observers say could serve as a catalyst for drug safety legislation.
Johnson & Johnson’s (J&J) embattled heart-failure medication Natrecor is again under fire after the company revealed last week that it failed to inform federal regulators about the deaths of two patients who participated in a clinical trial of the drug.
The House narrowly passed an amendment late June 8 that would effectively end the FDA’s use of conflict-of-interest waivers for members of its advisory committees.