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The way in vitro companion diagnostics for cancer drugs are labeled sometimes presents a challenge for oncology care, Commissioner Scott Gottlieb said Thursday in announcing new guidance to tackle the problem. Read More
HHS Thursday pushed back against criticism by conservative groups of its proposed demonstration project to link Medicare Part B drug pricing to those of other countries. Read More
The Federal Trade Commission endorsed FDA draft guidance that aims to deter drugmakers from gaming the citizen petition process to delay generics. Read More
Senators Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) introduced a bipartisan bill Tuesday that would strengthen Medicaid’s capacity to go after drugmakers suspected of misclassifying branded drugs as generics. Read More
Leading drug companies called for tweaks in the FDA’s draft guidance on postapproval changes for drugs to help clarify info and better align with ICH guidelines. Read More