David Skanchy

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David Skanchy was the Division Director (retired) at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

Articles

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Master File Submission of Structures

Barbara Scott;David Green;Marlene Kim;Naomi Kruhlak;Tyler Peryea;David Skanchy

January 15th 2024

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Latest Updated Articles

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

Buy, Sell, Hold: Cell and Gene Therapy - Part 1

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Published: September 10th 2024 | Updated: September 18th 2024

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

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Published: November 6th 2024 | Updated: November 19th 2024

Automate Aseptic Filling: Closing the System at Full Modularity

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Published: November 5th 2024 | Updated: November 19th 2024

Untethered Data: Unifying and Contextualizing Drug Discovery Data

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Published: November 8th 2024 | Updated: November 19th 2024

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

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Published: November 4th 2024 | Updated: November 19th 2024

Strategies for Overcoming Common Challenges in Tech Transfer

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