FDA Compliance Marketing Regulation 
XTalks
JANUARY 9, 2025
Fundamentally, the guidance brings forth the importance of a Total Product Lifecycle (TPLC) approach, a comprehensive strategy that considers every stage of a device’s journey design, development, market approval and real-world use to ensure long-term safety and effectiveness. Another key area is data management.
Intouch Solutions
NOVEMBER 18, 2021
Let’s talk about what that means for pharma marketers! Why Pharma Marketers Should Care About RSAs RSAs are a text ad format that requires an increased number of headline and description line variations than ETAs require. Among the concerns that pharma marketers face: The RSA ad format will be new to most MLR reviewers.
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FDA Law Blog
JANUARY 1, 2024
Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.
Cloudbyz
AUGUST 19, 2024
Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?
FDA Law Blog
JUNE 9, 2021
Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.
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