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U.S. Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach has announced the creation of a new office that will address cultural issues within the agency.
The U.S. Food and Drug Administration (FDA) issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children.
One-quarter of medical school IRBs have no written policy on potential conflicts of interest among members, and only one in five systematically collects information about members' potential conflicts of interest, according to a recent study.
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) under its new chairman, Samuel Tilden, has recommended ethics training for investigators, IRB members and others, and has proposed a definition of “minimal risk” clinical trials.
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) has a new chairman, Samuel Tilden, following the resignation last November of Ernest Prentice.
Two proposed rules from the FDA strike a “generally reasonable balance” between allowing patient access to investigational drugs and ensuring patient safety, although some changes still need to be made, Public Citizen said.
Women who take estrogen as hormone replacement therapy to counter the effects of menopause may be better off using a transdermal patch than swallowing a pill, according to a recent study.
Health Canada has released draft guidance for manufacturers and healthcare professionals detailing procedures under the special access program (SAP) for drugs.
The FDA wants to prohibit certain cattle material from drugs, biologics and medical devices to lower the risk of bovine spongiform encephalopathy (BSE or mad cow disease.)