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. Source: Drug Industry Daily

The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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…

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…