Generic Drugmakers Get Year-End Gift As FDA Backs Off Product-Liability Rule Proposal

At issue was proposed regulation that would have allowed generic drug companies to update their product labeling when new information about a medicine's safety is revealed, a move that could open drugmakers up to lawsuits. Commissioner Scott Gottlieb and the FDA’s drug-center director Janet Woodcock said in a statement, “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities."

from Kaiser Health News https://ift.tt/2GhPOS1