http://blog.pharmtech.com/2008/09/08/woodcock-opens-pdafda-conference/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2008/09/08/woodcock-opens-pdafda-conference/comment-page-1/#comment-8455 Adam Smith Sun, 14 Sep 2008 22:31:04 +0000 http://blog.pharmtech.com/?p=237#comment-8455 The FDA Globalization Act, a.k.a. "Small Business Destruction Act," will wipe out small manufacturers. My wife produces various soaps, and if the legislation is passes, we'll have to shut down the same day due to the huge fees and regulations. Her income is a very nice addition to our family. However, the Democratic senators and big corporations want to push us out of business. The FDA Globalization Act, a.k.a. “Small Business Destruction Act,” will wipe out small manufacturers. My wife produces various soaps, and if the legislation is passes, we’ll have to shut down the same day due to the huge fees and regulations. Her income is a very nice addition to our family. However, the Democratic senators and big corporations want to push us out of business.

]]> http://blog.pharmtech.com/2008/09/08/woodcock-opens-pdafda-conference/comment-page-1/#comment-8117 S C Burford Wed, 10 Sep 2008 02:28:57 +0000 http://blog.pharmtech.com/?p=237#comment-8117 Industry really should thank these ranking regulatory agency officials for their valuable insights. More determined effort to harmonize pharmaceutical regulatory requirements, expanded to embrace significant non-ICH stakeholders, seems inevitable if the regulatory agencies are to continue to be able to effectively meet their oligations, and ensure that companies also do so. In agreement with what Ms Drakulich astutely observes, I also hope that we will see a willingness to change and a real commitment to regulatory harmonization, from all major agencies. Industry really should thank these ranking regulatory agency officials for their valuable insights.
More determined effort to harmonize pharmaceutical regulatory requirements, expanded to embrace significant non-ICH stakeholders, seems inevitable if the regulatory agencies are to continue to be able to effectively meet their oligations, and ensure that companies also do so.
In agreement with what Ms Drakulich astutely observes, I also hope that we will see a willingness to change and a real commitment to regulatory harmonization, from all major agencies.

]]>