Biomedical groups propose a simplified system for the disclosure of potential conflicts of interests.
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GlaxoSmithKline will share long-sought, raw trial data—but access will be tightly controlled.
Pharmaceutical and biotech companies ask the US Food and Drug Administration to ensure the independence of a third-party audit of its new drug program.
Doctors question whether a government initiative to speed approval for promising new drugs is ensuring safety.
Top FDA officials, including Commissioner Margaret Hamburg, were aware the agency was monitoring staff emails discussing the safety of some approved medical devices.
A US federal court rules that procedures in which a patient's own stem cells are extracted, manipulated, and reinjected should be regulated by the FDA.
After treating terminally ill patients with an unauthorized experimental probiotic procedure, two California doctors can no longer participated in human research.
The federal agency's surveillance of staffers feared to be leaking confidential information about medical devices was wider than previously thought.
Chemists are already finding ways to circumvent a new federal law cracking down on marijuana and methamphetamine mimics.
The new law reauthorizes fees charged to drug and device makers, creates new fees for the approval of generic drugs.
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