이 에피소드에 관해
I have seen this time and again. A medical device manufacturer follows the available FDA guidance documents, goes to the pre-submission meeting, presents their case, and leaves feeling that the meeting went well. Imagine the surprise three weeks later when the FDA sends a three-page letter advising the manufacturer to incorporate elements of the draft guidance document that the manufacturer did not even know existed. In this episode, I try to explain this concept to Joe Hage.
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면책 조항: 이 페이지에 포함된 팟캐스트와 작품은 Michelle Lott에서 가져온 것입니다. 이 팟캐스트는 소유자의 재산이며 Listen Notes, Inc.와 제휴하거나 보증하지 않습니다.
