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.
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FDA Warning Letter Blasts Mylan’s Lax API Impurity Controls
Concerned about another possible nitrosamine scare, the US FDA has sent a warning letter to Mylan focusing on the firm’s failure to control contamination risks of its APIs and inadequate testing of reused solvents.
FDA Warning Letter Blasts Mylan’s Continued Lax Impurity Controls for APIs
Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.
Injector Failure Guidance From US FDA Aims To ‘Balance’ Reliability And Feasibility
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‘remote probability’ of failure equating to no more than one in every 100,000 injection attempts, agency says in a new draft guidance that may have relevance for other types of emergency-use drug delivery devices.