FDA’s “Balanced Approach” To Opioids Extols Naloxone Auto-injector
This article was originally published in The Pink Sheet Daily
Executive Summary
Top government officials hold two briefings on FDA’s approval of a naloxone delivery device for reversal of opioid overdose as the agency faces continued criticism for approval of Zohydro XR.
You may also be interested in...
FDA’s Naloxone Product Approval Standards May See Changes
Advisory committees will weigh adequacy of current pharmacokinetic requirements and pediatric dosing for novel formulations of the opioid overdose reversal agent.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.