An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?

Dear FDA, EMA and ANVISA, How are you?  I’m sure your summer has been busy, just like mine.  Hope you were able to get at least some time away.  I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday.  You know, the

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5 thoughts on “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?”

  1. Very interesting and relevenat letter indee!. Maybe expand the recipent list to more markets (excluding China as there has been enough time to adapt to that regulation now). With most markets the regulatations or part of are always in what seems to be a state of change making this letter very topically. I say put a stamp on it and post it. I would love to hear the reply.

  2. Precisely the same problem occurred when the Malaysian medical devices agency extended the deadline for new medical device registrations by a year recently. To make matters worst they announced the extension the very first day AFTER the expiry of the previous deadline.

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