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Fda Cms Pro Industry Initiatives

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Edward Berger
Edward Berger

The document discusses several recent "pro-industry" initiatives by the FDA and CMS that are intended to improve responsiveness to industry but have disappointed many companies. It outlines initiatives by each agency, as well as two joint initiatives, including improved information sharing between the agencies. However, the document notes that industry remains doubtful about the initiatives due to ongoing costs, uncertainty, and limitations of some programs. Barriers to successful implementation of the initiatives include limited agency budgets, staffing challenges, and lack of stable leadership.

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FDA/CMS “Pro-Industry” Initiatives: Good or Bad for Industry? April 12, 2011 Edward E. Berger, Ph.D. Larchmont Strategic Advisors
Defining the problem ,[object Object],[object Object],[object Object],[object Object]
FDA “pro-innovation” initiatives have disappointed many in industry ,[object Object],[object Object],[object Object],[object Object]
FDA drive toward improved responsiveness continues ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMS recent policy initiatives ,[object Object],[object Object],[object Object],[object Object],[object Object]
Industry doubts about the CMS initiatives ,[object Object],[object Object],[object Object],[object Object],[object Object]
Two major recent joint FDA/CMS initiatives ,[object Object],[object Object],[object Object],[object Object],[object Object]
Memorandum of Understanding 6/23/2010 ,[object Object]
Purpose of the MOU ,[object Object],[object Object],[object Object],[object Object]
Substance of the MOU ,[object Object],[object Object],[object Object],[object Object]
Some CMS/FDA data sharing has always occurred ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Purpose of parallel review ,[object Object],[object Object],[object Object]
There are precedents for parallel review ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What EPO and DESs had in common ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New initiatives level the field ,[object Object],[object Object],[object Object],[object Object]
Serious impediments to successful implementation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Edward E. Berger, Ph.D. Larchmont Strategic Advisors 2400 Beacon St., #203 Chestnut Hill, MA 02467 Tel: 617-645-8452 Email: [email_address] Thank You

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Fda Cms Pro Industry Initiatives

  • 1. FDA/CMS “Pro-Industry” Initiatives: Good or Bad for Industry? April 12, 2011 Edward E. Berger, Ph.D. Larchmont Strategic Advisors
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  • 17. Edward E. Berger, Ph.D. Larchmont Strategic Advisors 2400 Beacon St., #203 Chestnut Hill, MA 02467 Tel: 617-645-8452 Email: [email_address] Thank You