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November 19, 2015
As we discussed in a previous FDA News article, the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s ultimate goal...
November 12, 2015
FDA recently teamed up with the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) to develop and publish a draft guidance entitled, “Minutes of Institutional...
August 28, 2015
Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics.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...
April 1, 2013
On March 29, 2013, the FDA made available a draft guidance for Sponsors of biosimilar products outlining the procedures and processes for meetings with the FDA.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...