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Certain DMFs provided to support an application on packaging or packaging may be exempted from the electronic Common Technical Document (eCTD) format, the agency said. Read More
Reckitt Benckiser (RB Group) has entered into the largest opioid settlement in U.S. history, agreeing to pay $1.4 billion to resolve an investigation into its marketing practices for Suboxone film. Read More
Using real-world data (RWD) and real-world evidence (RWE) in clinical trials is growing in popularity among both industry and the FDA, but both groups agree that all stakeholders need to be on the same page when it comes to definitions and ways to measure results. Read More
The Trump administration pulled the plug last week on a rebate rule designed to lower drug costs — but Senate Finance Committee Chairman Chuck Grassley (R-Iowa) says a bipartisan package of reforms in the works will help shed light on pricing and rebates. Read More
The House Committee on Energy and Commerce voted Thursday in favor of amending the FAIR Drug Pricing Act of 2019, a bill that would require drug manufacturers to justify price increases to HHS. Read More