FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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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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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