It’s funny. Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document. When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.
That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance
This past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained. The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”. This time the book is available as a paperback and at the much more affordable price of only US$59.99.
I am working on Continue reading Announcing: The Second Edition of The Drug Supply Chain Security Act Explained
Even before the Drug Quality and Security Act (DQSA) was passed last November I began to study Title II, the Drug Supply Chain Security Act (DSCSA). But as soon as it was passed, I began to devote all of my spare time to that study. The DSCSA text is much more complicated than any previous U.S. drug pedigree law and so, to really understand it, I’ve read it through many times, concentrating on different parts at different times. I wanted to understand the law as well as I had come to understand the California pedigree law, the one that previously was the most complex.
It has taken this long, but I can now say that I have cracked it. Continue reading The Drug Supply Chain Security Act Explained
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