FDA Wary Of Industry’s New Pre-Market Review Goal Proposals
This article was originally published in The Gray Sheet
Executive Summary
Recent device industry proposals for more aggressive pre-market review goals could result in fewer device clearances and approvals, FDA warns.
You may also be interested in...
FDA Embraces Total-Time Pre-Market Review Goals, With Shared Accountability
FDA negotiators have warmed to the idea of total-time performance goals for the next round of medical device user fees, beginning in 2012, as long as FDA and industry share accountability for the time it takes to review new products.
FDA Embraces Total-Time Pre-Market Review Goals, With Shared Accountability
FDA negotiators have warmed to the idea of total-time performance goals for the next round of medical device user fees, beginning in 2012, as long as FDA and industry share accountability for the time it takes to review new products.
User Fee Talks On Schedule And Making Progress, Industry Says
Despite FDA warnings that time is running out for an agreement to be reached with industry on a user fee reauthorization plan, device industry leaders say the two sides have made “good progress” toward reaching a pact.