As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. Read More

A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More

Beginning today, new safety and efficacy findings that emerge during postmarket clinical trials should be reported in periodic safety update reports (PSURs) submitted to the European Medicines Agency (EMA). Read More

CDER Director Janet Woodcock told lawmakers the FDA’s current medical information system is outmoded and the agency is developing the Patient Medication Information (PMI) document — a single, standardized medication information leaflet — to fix it. Read More

A bipartisan federal budget deal reached Tuesday removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees, and would ensure they aren’t locked away along with some of last year’s payments. Read More

In a boost for big pharma, the European Medicines Agency raised the fee-reduction rate for non-small and medium-sized enterprises seeking assistance on adult-only protocol from 40 percent to 75 percent, effective Jan. 1. Read More

U.S. President Barack Obama Nov. 27 signed into law a bill establishing both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary U.S. Food and Drug Administration oversight of compounding pharmacies. Read More