See the attachments below for a series of white papers regarding global market access for specialty pharmaceutical, medical device and in vitro diagnostic products

 

Thoughts on the 510(k) Premarket Notification Process
510(k) Program Proposed Changes 01.19.2011
December 2011 FDA 510(k) Draft Guidance Summary
The Evolution of Combination Product Commercialization
FDA+CMS Pilot Program 

 

 

The following article on biosimilars regulation was recently published by Stephen Amato in Bio-IT World:

Biosimilars: Not So Similar to FDA Generic Drug Approvals

http://www.bio-itworld.com/2013/1/4/biosimilars-not-so-similar-fda-generic-drug-approvals.html 

 

The following article on the convergence of market access and regulatory variables was recently published by Stephen Amato in Pharmaceutical Compliance Monitor:

Optimizing the 3 P’s – Product, Pricing and Patient Outcomes – How Do We Get There?

http://www.pharmacompliancemonitor.com/the-experts/stephen-f-amato-phd-mba-rac-tjun17life-sciences-llc/