2001 Documentation Drug Development 
European Pharmaceutical Review
JULY 4, 2024
The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).
pharmaphorum
JANUARY 29, 2021
They wanted someone who had lots of experience in drug development, was a molecular biologist, and was stubborn enough to take on CRISPR!” On top of this, there are the well-documented manufacturing challenges that come with such a new field. “I billion in funding. About the author.
FDA Law Blog: Biosimilars
APRIL 23, 2023
Other challenges in the use of an external control include concerns over potentially important treatment imbalances between arms resulting in biases that were not documented or accounted for.
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