The US Food and Drug Administration (FDA) issued a warning letter to stem cell clinics about releasing unproven treatments which posed high health risks to patients.
Colorado passed a law requiring drug manufacturers to disclose the wholesale acquisition cost to prescribers in its effort to address the high cost of prescription drugs.
It is necessary for companies to prepare before an FDA inspection to ensure that they are in compliance. How should you develop a plan before an inspection? What are some of the benefits of forming a war room? FDA regulatory attorney Darshan...
Companies must develop a plan to ensure that they are in compliance with FDA regulations during inspections. How should they accomplish this goal? Join FDA regulatory attorney Darshan Kulkarni as he discusses how to put together a war room in...
How can you ensure readiness and compliance for FDA inspections? Join FDA regulatory attorney Darshan Kulkarni as he talks about how to prepare for FDA inspections, and what actions the FDA has jurisdiction to take against companies that do not...
How should your company prepare for FDA inspections? In this episode, FDA regulatory attorney Darshan Kulkarni discusses the steps companies should take to respond to an FDA inspection, and ensure compliance. Plus, what actions the FDA has...