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The International Generic Drug Regulatory Program has outlined the group’s priorities for the next four years, focusing on five initiatives geared toward harmonizing global regulations on generic drugs. Read More
The EMA is clarifying agency expectations on the implementation of risk-based models and exposure limits to prevent cross-contamination during manufacturing in a Q&A guideline, telling manufacturers that all products should have health-based exposure limits (HBEL). Read More
Sen. Charles Grassley (R-Iowa) has sent a letter to the Centers for Medicare and Medicaid Services, asking for investigation of the classification of Dilaudid and Prilosec. Read More
Sanofi and Regeneron intend to appeal a federal court injunction banning the sale of their cholesterol drug Praluent after a judge found the companies infringed an Amgen patent covering its Repatha. Read More
Following tradition, FDA Commissioner Robert Califf will leave the agency on Inauguration Day, when Stephen Ostroff — deputy commissioner for foods and veterinary medicine — will temporarily assume the role. Read More