By Jill Hartzler Warner, J.D.   The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children. Two years...

It has been decided by the Expert Committee constituted by the Ministry of Health & Family Welfare that waiver of Clinical trial in Indian population for approval of new drugs, which have...

As per the decision taken by the Expert Committee constituted by the Ministry of health & Family Welfare, all the Sponsors/ clinical trial applicants should ensure that the number of clinical trials...

NEW DELHI: Multinational pharmaceutical companies keen to conduct clinical trials for new drugs on Indians would have to ensure an early launch of those therapies in India if the trials result in...

It has been decided by the Expert Committee constituted by the Ministry of Health & family Welfare that all the sponsors/ manufacturers/ clinical trial applicants have to provide compensation to the trial...

  By: David G. White, Ph.D. FDA Voice   Today, “antibiotic resistance” is a widely recognized concern. With the rise of bacteria that are resistant to many, and in some cases, all...

  FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety...

THE Union Health Ministry is working on a proposal to provide accreditation to clinical trial centres, investigators and ethics committees — all of which will kept be out of the purview of...