In the News

Legislators from the House and Senate have released a new version of a draft bill aimed at modernizing regulations for diagnostics. For two years now, Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO), members of the House Energy & Commerce Committee, have been working to advance a draft of the so-called Diagnostic… Read more »

Dive Brief: FDA Thursday released new draft guidance outlining the agency's thinking on considerations for developing and labeling in vitro companion diagnostic devices for specific classes of oncology therapeutic products. The effort comes as the agency approves more targeted medicines for specific disease subtypes. But while targeted… Read more »

While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs). Background Since 2013, FDA has attempted to develop a new regulatory framework for… Read more »

In a surprise move Thursday (Dec. 6), bipartisan duos of House and Senate lawmakers released draft legislation that lays out a framework for FDA to regulate in vitro clinical tests, such as test kits and laboratory developed tests (LDTs). At first glance, the draft legislation appears to closely resemble a legislative proposal put… Read more »

GOP LAWMAKERS QUESTION AZAR, VERMA OVER PART B PROPOSAL Former physicians now serving as Republican lawmakers questioned Trump administration health officials last week over a proposal to link Medicare reimbursements for drugs administered in doctors’ offices with an international pricing index based on countries whose governments set… Read more »

A proposal from President Donald Trump to lower the drug prices in Medicare is seeing some obstacles from the Republican opposition. In an attempt to lower the drug prices in the US, Trump had proposed to base payments for certain drugs off of lower prices in other countries, in October. During a speech at the Department of Health and… Read more »

Republican opposition is building to a proposal from President Trump to lower drug prices in Medicare. The rare break between Trump and Republican allies follows an aggressive step from the president in October that would tie certain Medicare drug prices to lower prices in other countries, a departure from the traditional GOP… Read more »

New life could be brought back to the Harmony Way Bridge connecting Indiana and Illinois in New Harmony, Indiana, after a measure passed the U.S. House this week. The Restore Harmony Way Bridge Act, written by Rep. Larry Bucshon, passed unanimously. It clears the way for Indiana and Illinois to come together to talk about the future… Read more »

Republican lawmakers who worked as doctors expressed their concerns about President Trump's controversial proposal to lower drug prices with the president's health chief Thursday. The lawmakers in the GOP Doctors Caucus questioned Secretary of Health and Human Services Alex Azar in the meeting about a proposal Trump put forward in… Read more »

A bridge between two tri-state communities that has been closed since 2012  is one step closer to possibly re-opening. The Restore Harmony Way Bridge Act may be the last piece of the legislative puzzle for the communities of Crossville, Illinois and New Harmony, Indiana, towards re-opening the new harmony bridge and restoring… Read more »