We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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