FDA Approval Via "Living License" Gaining Backers, But Major Players Not Among Them
Executive Summary
Support appears to be growing for FDA to adjust its approval system, including moving away from what has been called an “all-or-nothing” process to include a limited-launch approval mechanism.
You may also be interested in...
Industry Skeptical Of User Fee Success, PricewaterhouseCoopers Finds
FDA may be wondering whether a lack of praise for its user fee program actually could be a criticism after a survey did not find overwhelmingly agreement the dollars were serving their intended purpose.
Industry Skeptical Of User Fee Success, PricewaterhouseCoopers Finds
FDA may be wondering whether a lack of praise for its user fee program actually could be a criticism after a survey did not find overwhelmingly agreement the dollars were serving their intended purpose.
PDUFA Talks: Four-Phase Review Flops; Automatic Extensions Back On Table
FDA and industry have moved to a more pointed debate of automatic review deadline extensions after the agency decided to drop its four-phase review process proposal.