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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 has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both. Read More
Biosimilar sponsors should take a risk-based approach when assessing similarity of a reference product’s quality attributes, the FDA said in new draft guidance — pitched as part of the agency’s effort to lower drug prices. Read More
A new pricing agreement will allow a leading HIV regimen to be rolled out in more than 90 low- to middle-income countries, at an average cost of $75 per patient, per year. Read More
The future of the pharmaceutical industry will involve increased use of master protocols, trial platforms and clinical-trial networks, said CDER director Janet Woodcock this week at a National Academies of Sciences, Engineering and Medicine workshop on real-world evidence in Washington, D.C. Read More