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…
The FDA recently took action against more than 500 websites for illegally selling unapproved prescription medicines through the mail — including opioids, antibiotics and injectable epinephrine — as part of…
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…
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…
The House Committee on Energy and Commerce is pressing Merck for explanations about a recent cyberattack, calling it a matter of national security. Source: Drug Industry Daily
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…
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…
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. Source: Drug Industry Daily
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…
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take a risk-based approach when assessing similarity of a reference product’s quality attributes, the FDA said in new draft guidance — pitched as part of the agency’s…