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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
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
Amid concerns of rising pharmaceutical prices, HHS finalized a rule threatening fines against drugmakers that knowingly overcharge hospitals and providers under the 340B drug discount program. Read More
FDAnews has compiled a list of the 21st Century Cures Act’s requirements and deadlines most relevant to the FDA and the pharmaceutical industry, including upcoming guidances, policies and public reports. Read More