Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.
The US Food and Drug Administration (FDA) is requesting a budget of $4.9bn for fiscal year (FY) 2016 – a 9% increase over the enacted budget for FY 2015.
The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.