Labeling Updates For Old Drugs Could Be Faster Under Streamlining Proposal

A streamlined pathway for adding important data to labeling of older drug products could encourage submission of more labeling supplements to better reflect products' current clinical use, but the idea seems to lack strong support from the US FDA and the generic drug industry due to a host of factors including complexity, resources and product liability concerns.

The proposal, aimed at bringing labeling for older drugs into line with current real-world practice, was introduced at the Friends of Cancer Research's (FOCR) recent annual meeting in Washington, DC....