We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A congressional lawmaker is proposing legislation that would force drugmakers to include the results of all pediatric clinical studies in product labeling — a requirement the FDA may implement through a proposed labeling policy.
As part of its continuing effort to accelerate drug development, the FDA’s Pharmaceutical Science Advisory Committee will meet Oct. 19 to evaluate research opportunities under the agency’s Critical Path Initiative.
Dietary supplement ephedra manufacturers have asked a U.S. District Court to invalidate the FDA rule banning the substance and to enjoin the FDA from enforcement action against the plaintiffs for the continued sale of ephedra in low doses.
There is some evidence to suggest an increased risk of suicidal behavior for children using certain antidepressant medications, the FDA said in a statement that at least partially vindicates findings made by FDA scientist Andrew Mosholder months ago.
The FDA has concluded there is evidence to suggest an increased risk of suicidal behavior for children using certain antidepressant medications, a conclusion that at least partially vindicates findings made by FDA scientist Andrew Mosholder months ago.
Industry group says that even though the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way in establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs.
Endo Pharmaceuticals has reached an agreement with the FDA on the design of a new clinical trial to confirm the safety and efficacy of its experimental pain drug, oxymorphone extended-release (ER) tablets, the firm said last week.
Endo Pharmaceuticals has reached an agreement with the FDA on the design of a new clinical trial to confirm the safety and efficacy of its experimental pain drug, oxymorphone extended-release (ER) tablets, the firm said yesterday.
The FDA has denied a citizen petition calling for the removal of Bristol-Myers Squibb’s (BMS’) antidepressant Serzone because of safety concerns — a move that allows generic firms to continue to market the drug, which no longer is sold by BMS.