Clinical Research Solutions
FDA Extends Comment Period For Its “Request for Quality Metrics” Draft Guidance
Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...
Regulatory Sciences
FDA Releases New Guidance on Meetings with Sponsors of Biosimilars
On March 29, 2013, the FDA made available a draft guidance for Sponsors of biosimilar products outlining the procedures and processes for meetings with the FDA. Although much of guidance for the...