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The FDA is taking issue with a new study that says the agency can’t tell if its risk evaluation and mitigation strategy (REMS) program for extended-release and long-acting opioids is effective. Read More
“By providing comprehensive, accessible learning tools, we will support outsourcing facilities in reliably producing high-quality compounded products that meet FDA’s standards,” said CDER Director Janet Woodcock. Read More
Merck is working with the WHO, UNICEF, the U.S. and Gavi, an international vaccine alliance, to create a plan for public health preparedness and response efforts. Read More
Lawmakers failed to enact drug pricing legislation in 2019 but they will be under intense pressure to try again in the new year as presidential campaigns begin to pick up steam. Read More
The 11-member committee voted to recommend the drug based on data from a multicenter trial. The overall response rate was 15 percent, with an overall survival of 82.4 weeks. Read More