Mark Crawford, Contributing Writer || June 2, 2015 There are more stringent regulatory requirements for sterilization and
packaging, in addition to increasing pressure on contract manufacturers from OEMs for data analysis, recording, reporting, review and validation.
Sandra White and Mehri Hezari-Adam, Ph.D. || November 13, 2014 As of October, the U.S. Food and Drug Administration (FDA) has approved or cleared 19 companion diagnostics (CDx),1 though that number is certain to rise as DNA sequencing continues to reveal intricate correlations between genetic signature and disea…
Ranica Arrowsmith, Associate Editor || September 10, 2013 Validation is not about a set of hard and fast rules—it’s about organically understanding a process and approaching process control with finesse.
James R. Ravitz || October 21, 2006 Promoting Medical Devices Prior
to FDA Approval or Clearance
James R. Ravitz,
Arent Fox PLLC
Earlier this year, this column examined the FDA’s regulations and trends with respect to direct-to-consumer advertising. Now we’ll exam…