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The FDA and the HHS Office of Human Research Protections finalized their joint guidance detailing requirements for keeping minutes of institutional review board meetings, as part of a push to harmonize research regulations across the government before 2020. Read More
The House Committee on Energy and Commerce is pressing Merck for explanations about a recent cyberattack, calling it a matter of national security. Read More
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