Marktanalyse - Congress on Track to Overcome Partisan Gridlock and Keep the FDA Afloat

Congress on Track to Overcome Partisan Gridlock and Keep the FDA Afloat


Summary


GlobalData's analysis alert 'Congress on Track to Overcome Partisan Gridlock and Keep the FDA Afloat' analyzes legislation recently passed by the United States Senate updating the Prescription Drug User Fee Act (PDUFA) and related provisions, which are set to expire at the end of September. Congress is locked in a pitched partisan battle regarding almost any topic that arises. However, when it comes to authorizing user fees and funding for the FDA for the next five years, legislators have found an astonishing amount of common ground. Renewal of the PDUFA legislation is necessary to keep the FDA moving forward, but it also contains numerous new, helpful provisions. For example, generics and biosimilars makers will now be subject to FDA user fees, which should speed up the review process for these products. Passage of a corresponding bill by the House of Representatives and reconciliation of the two pieces of legislation should happen in the coming weeks, yielding a clean FDA re-authorization bill ready for President Obama’s signature.


Scope

- Details of key provisions in the Senate PDUFA re-authorization.
- Amendments to the bill that were considered and either included or denied.
- Examination of the political landscape surrounding the bill’s passage.


Reasons to buy

- Important details of the legislation and its approval prospects are explained.
- Understand how new provisions of the PDUFA re-authorization will affect the pharmaceutical industry.

1 Table of Contents

1 Table of Contents 1

2 Summary 1

3 Congress on Track to Overcome Partisan Gridlock and Keep the FDA Afloat 1

3.1 Key Provisions of the Bill 1

3.2 Amendments Included in the Bill 2

3.3 Admendments that Didn’t Make the Cut 3

3.4 Disagreements Lie Ahead 3

3.5 The FDA Will Be Renewed 4

4 Appendix 4

4.1 Methodology 4

4.1.1 Coverage 4

4.1.2 Secondary Research 4

4.1.3 Primary Research 5

4.1.4 Expert Panel Validation 5

4.2 Contact Us 5

4.3 Disclaimer 5

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