The Food and Drug Administration will accept comments through Nov. 17 on draft guidance for labeling proposed biosimilar and interchangeable biosimilar products. The guidance would replace 2018 guidance to include recommendations for labeling interchangeable products, among other changes. The agency has approved 42 biosimilar products, including four interchangeable biosimilars. 
 

Headline
The U.S. Court of Appeals for the 5th Circuit April 9 affirmed rulings by a Mississippi district court that rejected requests by Novartis and PhRMA to enjoin…
Headline
The White House April 2 issued a proclamation implementing additional tariffs on certain patented pharmaceutical products and ingredients. The order imposes a…
Headline
The Centers for Medicare & Medicaid Services April 2 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription…
Headline
The AHA commented today on the Centers for Medicare & Medicaid Services’ proposed rule on the Global Benchmark for Efficient Drug Pricing Model, or…
Headline
The Administration for Strategic Preparedness and Response Feb. 18 announced an investment that will focus on resolving a frequent shortage of oseltamivir,…
Headline
The House Energy and Commerce Subcommittee on Health Feb. 11 hosted a hearing titled “Lowering Health Care Costs for All Americans: An Examination of the…