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).

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Therapies Engineering Production FDA 59

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

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Laboratories Assay Development Small Molecule Drug Development 52

Agency IQ

FEBRUARY 2, 2024

Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. Even under the shadow of the Covid-19 pandemic, 1.2

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Clinical Trials Trials Treatment Disease 40

Conversations in Drug Development Trends

JANUARY 6, 2025

End-to-end workflow automation, from sample receipt, processing, analysis, and reporting, will likely become an industry standard, making it an essential tool for drug development. Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drug development.

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Clinical Trials Trials Drug Development Therapies 52