August 26, 2008
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 →
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 →