What is an FDA warning letter, and how should your company respond once it has received one? In today's episode, Darshan Kulkarni talks with former FDA inspector Patrick Stone about the auditing process in compounding pharmacies, and how companies...
It can be difficult to bring drugs to market successfully. What can you do to ensure this process runs smoothly? Join Darshan Kulkarni as he discusses the steps required to bring a drug to market. Plus, the dangers of violating FDA regulations and...
Not all products have to meet the U.S. Federal Drug Administration’s (FDA) approval: certain biologics and dietary supplements do not require it, and there are alternative pathways for OTC drugs and other products to skip the process.
