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 ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

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 ...

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 U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved under the U.S. Food and Drug Administration's "Breakthrough Therapy ...

India, March 20 -- The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidelines outlining a ...