06 julio 2019

Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine .

Tres cuartas partes de los nuevos medicamentos obtienen una revisión reglamentaria acelerada, lo que empuja a las familias y los médicos a un nuevo mundo de compensaciones .

Por Peter Loftus , 5 de julio de 2019 .

For decades, most drugs for critical illnesses passed through a standard battery of tests before regulators allowed them onto the market. A smaller portion were “fast tracked” to make them available to patients sooner.

Now that dynamic has flipped. Most drugs are released faster than ever through federal programs expediting their approval.

The new normal is transforming medical decision-making for the seriously ill, especially those who are out of other options. Families and doctors are thrust into a new world of trade-offs, raising complex questions about the medical and financial value of drugs with limited track records. ...