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PhRMA’s CEO cited industry information silos and other barriers to sharing data, as well as clinical trial design issues, that could be modified to expedite the work. Read More
The FDA has failed to properly address safety issues relating to an over-the-counter teething medication and should act within 30 days to remedy the situation, a lawsuit by Public Citizen said. 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
Aegerion Pharmaceuticals pleaded guilty to two criminal misdemeanor violations of the FD&C Act, for failing to comply with REMS requirements for its Juxtapid (lomitapide) cholesterol therapy. Read More
The FDA is looking to get involved with sponsors earlier in the development process for new drugs, and to further help speed the drugs to market through improving the design of clinical trials, Commissioner Scott Gottlieb said. Read More