Injector Failure Guidance From US FDA Aims To ‘Balance’ Reliability And Feasibility
Executive Summary
Injectors used for emergency administration of drugs such as epinephrine should be demonstrate a ‘remote probability’ of failure equating to no more than one in every 100,000 injection attempts, agency says in a new draft guidance that may have relevance for other types of emergency-use drug delivery devices.
You may also be interested in...
Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product
Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.
Mylan’s EpiPen Recall: Adding Insult To An Injured Product
Pricing controversy around the product got the CEO hauled before Congress; now what began as an overseas recall of one lot made by a Pfizer subsidiary threatens to besmirch Mylan’s once golden supply chain quality record.
US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals
Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.