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Fees collected by the Danish Medicines Agency (DMA) for applications to conduct clinical trials on new medicines rose Jan. 1 to 7,010 Danish kroner (Dkr).
A recent trend among some European Union (EU) members to apply clinical trial regulations for medicines to medical devices is ill-conceived and not in the interest of device manufacturers, according to a position paper released by Eucomed, the European medical technology industry association.
All "unanticipated problems" affecting participants in clinical trials sponsored or supported by HHS must be reported, a new guidance from the Office for Human Research Protections (OHRP) says.
The process for institutional review boards (IRBs) to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
Bristol-Myers Squibb (BMS) and AstraZeneca announced that they are collaborating to develop and commercialize two experimental drugs for Type 2 diabetes.
Drug companies will increasingly outsource their clinical trials in the coming years, with “many top pharmaceutical companies” expecting to do up to 65 percent of their clinical trials abroad, according to the “Outlook 2007” survey by the Tufts Center for the Study of Drug Development (CSDD).
A Swiss study published Jan. 2 in the Journal of the American College of Cardiology (JACC) found that “collateral function” — the functioning of small “collateral” heart vessels — is more severely impaired in patients implanted with drug-eluting stents than in those implanted with bare-metal stents six months after implantation.
Drug companies will increasingly outsource their clinical trials in the coming years, with “many top pharmaceutical companies” expecting to do up to 65 percent of their clinical trials abroad, according to the “Outlook 2007” survey by the Tufts Center for the Study of Drug
Development.