Legal Use Case 7: A Conversation
Legal Use Case 7 Part II: The Prescription
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more
This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more
June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more