Daily Archives: August 26, 2008

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

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