2001, Documentation and Drug Development

Botanical drugs – what is the best way forward for regulatory and market approval?

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).

Drug Development

Drug Development Biosimilars Documentation Labelling

Gene editing: beyond the hype

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.

Documentation

Documentation Drug Development

FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

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.

Documentation

Documentation Drug Development

Pharmacist Digest

Botanical drugs – what is the best way forward for regulatory and market approval?

Gene editing: beyond the hype

FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

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