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An FDA policy proposal on expedited generic drug approvals runs counter to the goals of the program and breaks faith with the upcoming GDUFA II agreement with the industry, generic drugmakers said. Read More
The European Medicines Agency has hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. 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
A coalition of state attorneys general suing opioid manufacturers has expanded the investigation of marketing and sales practices to include several branded painkiller manufacturers and drug distributors. Read More