Glen C. Cheng, MD

Glen C. Cheng, MD, Regulatory Counsel, Office of Regulatory Policy, Center for Drug Evaluation and Research, FDA.

Articles

Time to GAIN: Are Your FDA Marketing Exclusivities Eligible for Extension?

Glen C. Cheng, MD;Shana K. Cyr, PhD;Jennifer H. Roscetti

May 7th 2018

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.

Latest Updated Articles

Published: October 11th 2024 | Updated: October 18th 2024

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Automate Aseptic Filling: Closing the System at Full Modularity

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Untethered Data: Unifying and Contextualizing Drug Discovery Data

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Published: November 8th 2024 | Updated: November 23rd 2024

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

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