Drug manufacturers developing OTC drugs have a lot of important decisions to make. One of these decisions is determining which regulatory pathway works best for their product. In this episode, Darshan discusses how the OTC monograph process takes...
A grey area within bioethics presents some very challenging questions as it becomes increasingly harder to distinguish what is moral and immoral in the realm of science. Join Darshan Kulkarni as he talks about the importance of bioethics, and some...
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...
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...
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...