Reviewing The Reviewers: FDA Divisions Get Mixed Results In BIO Survey
FDA-sponsor interactions vary widely, but more meetings still seem to speed applications; Special Protocol Assessments fall out of favor.
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PwC Health Research Institute’s survey of 100 senior executives found 43% support FDA use of economic data in deciding whether to approve a drug, up from 14% four years ago.
FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More?
FDA has noticed a perplexing – and somewhat vexing – trend among smaller, less experienced pharma companies: They are not taking full advantage of a new liaison program designed to increase sponsor/FDA communication – even when they hit roadblocks during the drug review process. FDA officials have heralded the program as one of the most important under PDUFA V. So why aren’t companies using it?
The director of the agency’s patient focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.