A Blueprint for Helping Children with Rare Diseases
The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children.
Read MoreWAIVER OF CLINICAL TRIAL FOR NEW DRUG APPROVAL IN INDIAN PATIENTS
It has been decided by the Expert Committee that waiver of Clinical trial in Indian population for approval of new drugs, which have already been approved outside India
Read MoreLIMITING NUMBER OF CLINICAL TRIALS AN INVESTIGATOR CAN UNDERTAKE
As per decision taken by the Expert Committee the investigator of clinical trial should not be involved in conduct of more than three clinical trials at a time.
Read MoreDrug Controller General of India to pharma MNCs: Conduct fruitful clinical trials for Indians
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 commercial production, the drug regulator has said.
Read MoreCOMPENSATION FOR CLINICAL TRIAL IN CASE OF INJURY OR DEATH DISCERNED AT A LATER STAGE
Decided by the Expert Committee, all the sponsors/ manufacturers/ clinical trial applicants have to provide compensation to the trial participant/his/her nominee if any drug- related anomaly is discerned and accepted to be drug related injury or death.
Read MoreKeeping You Informed: An Update on FDA’s Judicious Use Strategy for Antimicrobial Drugs in Food-Producing Animals
Today, “antibiotic resistance” is a widely recognized concern. With the rise of bacteria that are resistant to many, and in some cases, all standard treatments, scientists and medical professionals are not alone in focusing on this problem.
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REQUIREMENT OF LOCAL TRIAL FOR A GENERIC OR BIO-SIMILAR IN OTHER COUNTRY LIKE USA FOR ITS APPROVAL IN THE COUNTRY
The drugs considered generics and similar biologics (biosimilars) in other countries like USA that have been marketed in such countries for more than four years and have a satisfactory report would be approved for marketing in India
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FBO must adhere to FSSAI guidelines, published on website of regulator
Health minister Dr Harsh Vardhan stated that food business operators (FBO) have to adhere to the advisories and guidelines issued by FSSAI since 2011, the year the Food Safety and Standards Regulations (FSSR) were implemented
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FSSAI extends food licensing, registration deadline to February 4, 2015
FSSAI has extended the deadline for obtaining licences and securing registration for FBOs under FSSR, 2011, by six months. The new deadline is February 4, 2015