Postmarket Safety

Woodcock to Lead Planned Pharmaceutical Quality Super Office

CDER Director Janet Woodcock has decided to head the FDA’s new Office of Pharmaceutical Quality (OPQ) herself until it gets off the ground. The new office is planned as a “super office” that will oversee manufacturing quality throughout a drug’s lifecycle. Read More

Appeals Court Tosses Generic Reglan Case

Admitting generic drug users are caught in a catch-22, a federal appeals court has dismissed liability suits brought by patients that took the generic version of Reglan (metoclopramide). Read More