As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all about and what is at stake.
Fortunately at Arnold & Porter, Daniel Kracov – a partner and head of the FDA and Healthcare Practice Group, has written a piece published in the September issue of Pharmaceutical Executive entitled "The Complete Pharma Exec Guide for PDUFA, What Congress’s Grand Plans for the "Revitalization" of FDA Really Mean…Besides More Red Tape" and it provides an excellent overview of what is contained in both the House and Senate versions of the bill, as well as discussing many of the implications.
You don’t need to be a "pharma exec" to get a lot out of the article. The piece covers the impact on devices, risk management strategies, labeling, safety information and direct-to-consumer advertising and much more and provides valuable insight into some of the things companies should be considering now related to the future. Check it out.