Tag: FDA

Over 100 million animals are used in laboratory experiments worldwide every year. These are only estimates; the exact number is unknown and could possibly even be higher. These animals are either killed outright in scientific procedures, or used to assess the safety and efficacy of drugs and cosmetics. ......

Before a new drug, biologic or medical device is approved and authorized for market launch, it has to undergo a long and complex process involving extensive testing and clinical trials to ensure its safety and efficacy. However, for patients who have exhausted all other options, sometimes an unapproved or pre-approved or investigational drug could be the only hope. ......

India is the largest producer of generic drugs in the world, and thus, it is no surprise that a great deal of patent litigation in India has centred on the manufacture of generics. While there are provisions in the law that permit the use of patented drugs for research and development (“R&D”) and for obtaining regulatory approvals, permissibility around the export of such drugs for similar purposes can be in the grey. ......