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In some EU countries up to 50% of European Medicines Agency-approved drugs are not available due to governmental or insurance-related barriers, and this impacts not only patients but also clinicians who miss the chance to become familiar with these therapies, he says. Further hurdles include the disparity in drug availability across Europe.
International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).
These concepts were then further evaluated during a workshop with specialty pharmacy stakeholders, during which turnaround time emerged as a high priority for measure development. ready for pick up or scheduled for delivery). Differring patient needs or preferences require different coordinated approaches.
Given the public health emergency, health authorities offered greater flexibilities in the use of digital health platforms and technologies such as: Enhanced HIPAA (Health Insurance Portability and Accountability Act of 1996) flexibilities in the use of telemedicine services 3. Published May 2006. 33 HealthXL. Published September 2021.
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