We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Saint Regis Mohawk tribe asked a federal agency to dismiss several challenges of the patents it now holds for Allergan, arguing the tribe is a sovereign nation and immune to such challenges. Read More
The FDA sent Intellipharmaceutics a complete response letter for Rexista — an extended-release oxycodone tablet rejected in July by an FDA advisory committee — calling for additional studies of the drug’s abuse-deterrent properties. Read More
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