Clinical Trials Advisor

The FDA has released a new manual of policies and procedures, or MAPP, establishing timeframes and deadlines for IND applicants and Center for Drug Evaluation and Research staff to follow.

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.

The biggest hurdle to conducting clinical trials in rare diseases is identifying and setting up investigative sites, according to a study of biotech and pharma companies vested in orphan drug development.

The European Medicines Agency (EMA) on May 2 published draft guidelines aimed at facilitating global development of biosimilars and avoiding unnecessary repeats of clinical trials.

An FDA advisory committee on May 2 rejected two proposed cancer therapies — a tyrosine kinase inhibitor targeting advanced renal carcinoma and a drug-device combination product for treating a deadly form of liver cancer.

The General Court of the European Union has issued a temporary injunction barring the European Medicines Agency (EMA) from releasing information on clinical data.

Academic clinical investigators conducting translational research should understand the risks and refuse to be deterred by negative clinical trial outcomes, says Douglas Mann, a professor of medicine at Washington University in St. Louis, Mo.

The FDA has granted CytRx a special protocol assessment (SPA) for its cancer drug aldoxorubicin to treat soft tissue sarcoma.