FDA Clarifies Modification Process For Blood Products

Law360, Washington (June 3, 2013, 4:30 PM EDT) -- The U.S. Food and Drug Administration on Friday released draft guidance to streamline the process for manufacturers of blood products like platelets modifying already-approved products, saying it wanted to clarify when and how a manufacturer must report a modification.

FDA broke down the changes into three different groups, depending on the effect the changes could have on the product, ranging from significant manufacturing changes and equipment upgrades to contractor switches or minor changes made soon after approval.

The recommendations are meant for companies making approved human...
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