Specialty Pharma Journal Specialty, Precision & Technology
In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration today issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. The powerful new technology, known as …
Tag Archives: guidances
July, 2016
April, 2015
-
29 April
FDA Issues Three Final Guidance Documents on Biosimilars
The US Food and Drug Administration (FDA) has issued three long-awaited documents with final guidance on biosimilars. In 2010, the agency passed the Biologics Price Competition and Innovation Act (BPCI) under the Patient Protection and Affordable Care Act. In 2012, the FDA released the first guidance documents in draft form. …