Gary Buehler

home / authors / gary-buehler

Gary Buehler is director of the Office of Generic Drugs at the US Food and Drug Administration.

Articles

Quality by Design for Generic Drugs

Quality by Design for Generic Drugs

Robert Lionberger;Gordon Johnston;Lawrence X. Yu;Gary Buehler;Michael C. Olson;Helen Winkle

October 2nd 2009

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy

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

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

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

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

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com

Published: November 6th 2024 | Updated: November 20th 2024

Automate Aseptic Filling: Closing the System at Full Modularity

Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com

Published: November 5th 2024 | Updated: November 20th 2024

Untethered Data: Unifying and Contextualizing Drug Discovery Data

Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com

Published: November 8th 2024 | Updated: November 20th 2024

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

Man touching a knowledge sharing concept | Image Credit: ©thodonal - stock.adobe.com

Published: November 4th 2024 | Updated: November 20th 2024

Strategies for Overcoming Common Challenges in Tech Transfer

Editorial Advisory Board

Do Not Sell My Personal Information

Terms and Conditions

Contact Info

2 Commerce Drive
Cranbury, NJ 08512

© 2024 MJH Life Sciences

All rights reserved.