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A congressional committee has requested that Amgen and Johnson & Johnson (J&J) stop direct-to-consumer (DTC) advertising for erythropoiesis-stimulating agents (ESAs). Read More
Lester Crawford, the former FDA com-missioner who abruptly left the agency two months after being confirmed, pleaded guilty to failing to disclose financial conflicts and making false statements, but is unlikely to spend more than a few months in prison, his attorney says. Read More
The Journal of the American Medical Association (JAMA) July 19 published a correction the second in a month in which they said the authors of an article did not disclose ties to the drug industry when they submitted their article manuscript. Read More
Medical journal editors are cracking down on authors who fail to disclose ties to drug or device companies, following several journal disclosures that peer-reviewed articles were written by freelance writers hired by drug companies. Read More
Financial conflicts of interest are common in FDA drug advisory committee meetings, a report by a frequent critic of the FDA says,
necessitating a more aggressive effort to change this process. Read More
The European Union recently implemented the EU Clinical Trials Directive to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17).
The chief of the geriatric psychiatry branch at the National Institute of Mental Health (NIMH) is being investigated by several separate government bodies over allegations he wrongly received
almost $600,000 from Pfizer.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, 2005, Page 1) (http://www.fdanews.com/cta/10_22/ctrial/48541-1.html).
Getting written informed consent can be tricky when conducting clinical trials in developing countries, particularly when the local population cannot read and write.
Efforts to limit the FDA’s ability to grant conflict-of-interest waivers for advisory committee members would undermine its ability to have the necessary expert advice needed to make drug policy, an agency official says.