Zdrowie i gospodarka · 22/01/2013

FDA Releases Draft Guidance for Postapproval Changes to Combination Products

The Food and Drug Administration (FDA) has made available a draft guidance document outlining the principles for determining the type of marketing submission required for postapproval changes to combination products approved under a Biologics License Application (BLA), a New Drug Application (NDA), or a Device Premarket Approval Application (PMA).