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...

G.S.R 346 (E)- Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required by section 12 read with section 33 of the Drugs...

Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice...