Author: Brittany Bos

 

The FDA’s Drug Approval Process- Part 3 of a 3-part series

by Christie Bell, CLP Final Steps and FDA Assistance This is the third and final article of a three-part series written to orient inventors of FDA regulations and requirements for consumables, drugs, and devices. In Part 1 we introduced an overarching scope of the purpose and process of the FDA.Read More

The FDA’s Drug Approval Process – Part 2 of a 3-part series

by Christie Bell, CLP The timeline, steps and cost. When not expedited by special programs, the standard drug development process can take from 10-15 years. For more in-depth information on the four special programs (Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review) please review Part 1 of this 3-partRead More

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