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China’s high court called for severe criminal punishments for deliberately falsifying drug clinical trial reports and other related documents, issuing a judicial interpretation that took effect Sept. 1. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
The Drug Enforcement Administration is proposing to lower its annual manufacturing limits on certain controlled substances for 2018 — which would cut back production of several classes of opioid painkillers and other scheduled pharmaceuticals, some between 10 and 25 percent. Read More
The European Medicines Agency developed a continuity plan to handle the workload linked to the UK’s withdrawal from the European Union and the relocation of the EMA’s headquarters. Read More
The FDA has agreed to fully share information from its inspections of drug manufacturers with its European Union counterparts, including for the first time trade secrets, the agencies announced. Read More
The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices. Read More
The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks. Read More
More than a dozen pharmaceutical industry leaders agreed to work together to develop new painkillers without the harmful addictive effects of opioid medicines — and to use the NIH as a central clearinghouse for research to speed up product development. Read More
To help relieve uncertainty among sponsors about its role in regulatory decisions, the FDA will publish guidance on its application of real-world evidence to drug approvals and post-market evaluations, FDA Commissioner Scott Gottlieb told the National Academy of Sciences. Read More