Opioid Blister Packs Need Study Before Mandate, Groups Urge
Executive Summary
AAM, Upsher-Smith, APhA, and Cigna tell US FDA that packaging requirement will increase manufacturing and drug costs, create reimbursement hurdles and reduce access to medicines. Daiichi-Sankyo supports agency's proposal.
You may also be interested in...
OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.
US FDA May Seek Legal Authority To Require Superiority Tests For Future Opioids
Commissioner Califf testifies at budget appropriations hearing that the agency may ask Congress to give it authority to require a new opioid drug application to show superiority to opioids on the market.