Tag Archive | "fda"

PAT, QbD and Process Validation – The Enablers of Pharmaceutical Quality


This presentation delivered by Vibhaker Shah, Ph.D., FDA Senior Policy Advisor, is a great reference resource on the merits of QbD, PAT and their links to the fairly new Process Validation guidance.

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Is QbD a Mandate for Generics? FDA Responds to Confusion


By Paul Thomas, Senior Editor

Last fall, FDA’s Lawrence Yu, deputy director for science and chemistry in the Office of Generic Drugs, said the following:

“As we’ve said many, many times, FDA Office of Generic Drugs expects QbD applications starting January 2013. You heard right, full implementation of QbD in January 2013.”

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Tech Transfer’s New Framework


Technology transfer has become a more critical, yet more complex, concern for many drug manufacturers—especially larger companies that have sought to bolster their pipelines through acquisition. In such cases, say Bikash Chatterjee and Mark Mitchell of Pharmatech Associates, “the control and consistency of development data can vary dramatically.”

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von Eschenbach: Why FDA Lags Behind


Former FDA Commissioner Andrew von Eschenbach took to the Wall Street Journal this week to weigh in on the problems of his former employer, and to encourage Congress to better support the Agency. FDA doesn’t have the “scientific tools and resources” it needs, von Eschenbach writes. (Registration required for full article.)  “Congress has starved the agency of critical funding, limiting its scientists’ ability to keep up with peers in private industry and academia. The result is an agency in which science-based regulation often lags far behind scientific discovery.”

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Drug Manufacturing: Still Waiting for the Sea Change?


In Pharmaceutical Manufacturing’s April issue cover story, Agnes Shanley takes “The Pulse of Pharmaceutical Manufacturing.” The past decade has seen dramatic shifts in the way we talk and think about drug manufacturing, but, she asks, have practices really changed in the time since FDA’s PAT team was formed and then-Commissioner McClellan wondered why pharma manufacturing was “behind that of potato chip and soap making”?

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Ajaz Hussain on the State of Pharmaceutical Manufacturing


By Agnes Shanley, Editor in Chief

PharmaQbD: Has drug manufacturing advanced in the last decade?

A.H.: I’ve probably kept up more on the regulatory side and what’s happening with different companies. The progress seems to be slow when one looks at news reports on shortages, recalls and other quality issues. Prevention of such issues was, in part, the motivation for FDA to launch the PAT and then the CGMP for the 21st Century Initiative.

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