Federal Advocacy

Congress has approved a continuing resolution that would temporarily block the Office of Management and Budget (OMB) from implementing its...

The Prescription Drug User Fee Act, or PDUFA, allows the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical and...

The U.S. Food and Drug Administration (FDA) and Securities and Exchange Commission (SEC) have signed a first-of-its-kind memorandum of...

The White House’s agreements with nine additional manufacturers signal that pricing pressure is extending deeper into the biopharmaceutical...

Two proposed Medicare payment models could have consequences well beyond drug pricing. The Global Benchmark for Efficient Drug Pricing, or...

Protecting the United States from genuine biotechnology threats is essential. But treating medicines like microchips could unintentionally weaken...

The new pathway would align FDA and CMS evidence expectations earlier, potentially accelerating Medicare coverage.

The latest round of U.S. tariffs provides important relief for pharmaceutical manufacturers but leaves much of the medical technology sector...

Medical technology organizations and regulatory experts are broadly supporting the proposed Medical Device User Fee Amendments VI agreement, while...

MichBio has joined the Medical Device Manufacturers Association (MDMA) and 13 other state life sciences organizations in urging the U.S. Trade...

MichBio has joined the Plant Based Products Council (PBPC) and dozens of national organizations in signing a coalition letter supporting H.R....

Earlier this month, BioLink highlighted the Office of Management and Budget's (OMB) proposed revisions to its Guidance for Federal Financial...