Monthly Archives: August 2008

For Investors

Here is a new addition to the Eye on FDA YouTube channel going under the Investment Vids playlist from Morningstar on Biotech stocks to watch.  Morningstar associate director of equity research Debbie Wang offers her take on possible takeout targets: … Continue reading

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Weekly Roundup – 08/29/08

Yesterday I turned another year older and was so mesmerized by that fact that I was unable to write a posting – forgive me.  Also, I’ve got that "end-of-August-I-don’t-want-to-go-back-to-school" feeling that I’ve never been able to shake in adult life.  … Continue reading

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Abbott Has YouTube Channel

Well, the other day I noted that Lilly had opened up a YouTube account called Lilly Diabetes and a few hours later, the site was closed.  I discovered yesterday a new Abbott YouTube site called Abbott1888 – not sure what … Continue reading

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FDA Issues New Complete Response Letter

Pursuant to my posting earlier today, by coincidence, Johnson & Johnson announced the receipt of a Complete Response Letter.  It is worth noting that they provided no details about the contents of the letter, except to say that there were … Continue reading

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Approvable Letters/Not Approvable Letters Replaced at CDER by Complete Response Letters – Why it isn’t Potato/Potahto

On August 11, the Center for Drug Evaluation and Research (CDER) put into force a new final rule on the way it respond to New Drug Applications (NDAs) that effectively did away with Approvable Letters and Not Approvable Letters in … Continue reading

Posted in FDA Policy | 1 Comment