FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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Therapies Engineering Production FDA 59

Agency IQ

JULY 21, 2023

That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors. But unlike ORR, PFS is considered by FDA to be a more appropriate measure of stable disease and is thought to be correlated to overall survival.

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FDA Clinical Trials DNA Treatment 40

The Pharma Data

MARCH 20, 2021

Accurate and timely laboratory diagnosis of COVID-19 is one of the most pivotal requirements for optimal disease management and contact tracing. A schematic of domain and functional organization of two of the major structural proteins of SARS-CoV-2, Nucleocapsid protein as a target viral antigen for assay development.

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Virus Assay Development Laboratories RNA 52