Drug makers now need government approval for any quality changes to medicines. This applies to alterations affecting a drug's ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Health ministry to amend NDCT Rules on reporting of post approval changes: Gireesh Babu, New Delhi Friday, February 6, 2026, 08:00 Hrs [IST] The Union ministry of health has initi ...

Sept 3 (Reuters) - The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including ...

New Delhi: In a move to spur drug innovation and restore fairness in the regulatory ecosystem, India’s top drug authority plans to overhaul a rule that puts early applicants for new medicines at a ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker ...

The agency expanded use of an old drug as a treatment for some people with autism. The endorsement sent some customers scrambling to buy over-the-counter supplements with the same ingredients. By ...

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...