Federal Advocacy

For biotechnology companies, adopting a new testing method requires confidence that its results will support both scientific decisions and...

CMS has finalized its Global Benchmark for Efficient Drug Pricing (GLOBE) Model, establishing a mandatory Medicare demonstration that uses...

MichBio is calling on Michigan’s congressional delegation to intervene before research funding from the National Institutes of Health (NIH)...

A bipartisan group of House lawmakers has introduced legislation to permanently authorize an important federal incentive for rare pediatric drug...

The Senate Committee on Agriculture, Nutrition, and Forestry advanced the Agricultural Act of 2026 on September 16, moving a long-delayed Farm...

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...

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...