Month: April 2020

 

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

The FDA’s Drug Approval Process – Part 1 of a 3-part series

Guest post by Christie Bell, CLP As the global race to find a vaccine for COVID-19 (novel coronavirus) speeds up by the hour, biotech companies with a potential solution to the pandemic, but who aren’t familiar with the Food and Drug Administration (FDA) approval process, are feverishly seeking primer-level informationRead More

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