FDA officials gear up staff to follow "least burdensome" criteria through series of internal briefings
This article was originally published in Clinica
Executive Summary
Stung by industry criticism, the US FDA has begun a concerted effort to prove that it is giving serious weight to the "least burdensome" provisions of the FDA Modernization Act of 1997 (FDAMA).
You may also be interested in...
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
World-First Nod For Yuhan's Lung Cancer Drug, In Korea
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes Gains US FDA Clearance For Velys Robot For Total Knee Surgery
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: