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The FDA is taking public comments ahead of a United Nations meeting that plans to add 10 drugs to international lists of controlled substances, including several relatives of powerful street drugs. Read More
The FDA is clearing up its annual reporting requirements for wholesale distributors and third-party logistics providers (3PL), explaining who must report and when to submit filings, among other clarifications, in a draft Q&A guidance. Read More
The Supreme Court has rejected Mylan’s challenge to a Federal Circuit decision that generic-drugmakers can face patent suits anywhere they may make sales in the future. Read More
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