One of our magazine’s regular and most popular contributors is John Avellanet, managing director and principal of Cerulean Associates. (His most recent article, from our June issue, focuses on data integrity and understanding FDA’s current thinking on 21 CFR Part 11.)

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This just in from FDA this morning….(one hopes that “parallel review” doesn’t mean opinions that never intersect):

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies.

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by Agnes Shanley

I was waiting for a formal announcement from FDA or EMA, but IPQ publications scooped everyone, by reporting earlier this month on the fact that FDA and EMA will be conducting a pilot program for joint review of the quality-by-design component of new drug marketing applications. (To access their report, with embedded links to relevant articles, including a look at the negotiations leading to this news, click here.)

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Pharmaceutical Quality by Design received an unofficial boost in comments made by the outgoing chief of the European Medicines Agency, in an interview with The Wall Street Journal this week. He suggests that global regulatory harmonization is an “unstoppable” force.  Read on for reportage from FierceBiotech, and a link to the original source (which requires registration).

Why is it that drug manufacturing is still batch driven? Why have tablet presses fundamentally not changed in 150 years? Why is tobacco production several sigma beyond pharma?

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