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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The Pharma Data

NOVEMBER 18, 2020

The consolidated feedback from the physicians who have participated in hands-on workshops, is very positive. Kai-Uwe Schässburger Director Clinical Development & Medical Affairs +49 (0)151 688 092 41 or + 46 (0)762 386 153 e-mail: kai-uwe.schassburger@neodynamics.com.

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Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Agency IQ

JULY 13, 2023

December 31, 2022 [link] PDUFA 50 issue a new MAPP on approaches to address CMC challenges for CDER-regulated products (drugs, biologics) with accelerated clinical development timelines (e.g., products used to diagnose, treat, or prevent a serious disease or condition where there is unmet medical need).

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Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. A year later, a similar workshop was conducted that included biologics and nonclinical models for efficacy, as well as modeling and simulation for dose-finding and dose optimization trials design.

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Agency IQ

AUGUST 2, 2024

On the medicines side, the EMA’s Methodology Working Party is slated to take on guidelines on the use of AI in clinical development. Analysis and what’s next Even with HHS re-organizing to take a more concerted lead on AI policy, the FDA is continuing ahead with its own projects.

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