Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.
Author: Mark Belsey, George Green
Publisher: Datamonitor Healthcare
Number of pages:37
Report code:DMKC OO97439
Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers, standardize Risk Evaluation and Mitigation Strategy plans, and cut drug shortages. However, approval times are increasing by 2 months.
On the intellectual property front, the new patent reform bill – the America Invents Act enacted in September 2011 – brings greater uniformity between the US patenting system and other major markets through a range of measures. It aims to improve the quality of patents (which tends to be lower in the US compared to Europe) and improves certainty in litigation.
Table of Contents
4 EXECUTIVE SUMMARY 6 US DRUG REGULATORY ENVIRONMENT
6 Drug approval and regulatory environment 25 US INTELLECTUAL PROPERTY LANDSCAPE
25 Overview of US patenting environment: how a patent is submitted and how generics get on
25 Patent reform bill introduces a range of new provisions to improve efficiency of the patenting
27 Raising patent quality is key, given the high chance of generics challenges leading to litigation
or settlements 28 BIBLIOGRAPHY 37 APPENDIX
LIST OF FIGURES
6 Figure 1: The structure of the FDA’s health functions
7 Figure 2: NME and BLA approvals, 2001–12
8 Figure 3: FDA median approval times for priority and standard reviews, 2001–10
9 Figure 4: Percentage of original applications approved, by review priority, per year of
10 Figure 5: New molecular entities approved in the US, 2003–11
13 Figure 6: Therapeutic area focus of comparative effectiveness research funding through ARRA
14 Figure 7: The non-linear relationship between OS and PFS in CRPC
17 Figure 8: Drug shortages in the US, 2005–10
21 Figure 9: The top 10 pharmaceutical companies in terms of followers on Twitter, January 2013
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