FDA Is Considering Faster Clinic Trials

The regulatory agency is considering a quick way of finding treatment for obese and develop life-saving antibiotics and other socially significant drugs

The new policy will allow the makers of such drugs to conduct smaller and faster clinical trials

Spokesman of the U.S. Administration of FDA Margaret Hamburg said that the regulatory agency is considering a quick way of finding treatment for obese and develop life-saving antibiotics and other socially significant drugs.
The new policy will allow the makers of such drugs to conduct smaller and faster clinical trials and to introduce the words “special medical use”, allowing physicians to grant experimental drugs in case of critical need. According to Ms. Hamburg, FDA should consider the needs of people with deadly or debilitating diseases that may be willing to take experimental drugs.
According to Alan Kuke – Deputy Director of Medical Programs at Pew Health Group, a new way of development, which would allow the product to reach the market faster and would make use only of patients with high risk / benefit would be a significant improvement. That would be good for manufacturers, patients and public health, he said.
Currently expedited consideration of clinical documentation is only available in a limited number of cases. Furthermore, although anti-cancer drugs are considered a priority, clinical trials have a normal period and number of volunteers.
Among the few companies enjoying an accelerated review of their products is Ziopharm, which are planning to develop and commercialize new anticancer therapies. The portfolio of the company consists of five products under study. Molecule in the most advanced stage – palifosfamid should hit the market at the end of 2012.

Source : dailyhealtharticles[dot]com