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.

Therapies 59

Therapies Engineering Production FDA 59

The Pharma Data

MARCH 20, 2021

Cell culture for virus isolation also remains a useful method for growing and studying viruses in research settings especially in the characterization of novel pathogenic viruses like SARS-CoV-2 although this requires more advanced containment facilities such as biosafety level 3 (BSL-3).

Virus 52

Virus Assay Development Laboratories RNA 52

Agency IQ

JULY 21, 2023

In 2019, the advocacy organization, Friends of Cancer Research (FOCR) organized a multi-stakeholder initiative comprised of industry, government, and academia to find out. In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology.

FDA 40

FDA Clinical Trials Treatment Trials 40