Drug Developers Facing "Unsettled" Period Of 5 To 10 Years As CER Environment Evolves, FDA's Woodcock Says
Executive Summary
The growing emphasis on comparative effectiveness research as well as the many unknowns on how the process is going to evolve could create a decade of unsettlement for drug development, FDA's Janet Woodcock said
You may also be interested in...
Reimbursement As Important As Regulatory Risks In Investment Decisions – Venture Capitalist
Venture capitalists are considering whether payers will pay and what reimbursement codes are available as they assess whether to put their money in companies with new medical products, a St. Louis venture capitalist tells regulatory affairs specialists in Seattle Oct. 28.
Lack Of Cost-Effectiveness Analysis For Products In Development Could Affect Company Valuations, Attorney Mahinka Says
With payers playing a more prominent role in determining access to drugs, developers will need to focus more on the comparative value of a drug throughout the development cycle, including cost. That value equation also will become an important part of the M&A landscape, attorney Stephen Mahinka says.
FDA And CMS Agree To Share Data Routinely In Step Toward Parallel Reviews
A June 23 memorandum of understanding on data sharing could serve as a first step toward parallel reviews by FDA and CMS for marketing approval and Medicare coverage, according to FDA