Researchers say they found that current ICDs are vulnerable to computer attacks that could compromise patient safety.
FDA warns Spains Interquim about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Senate Judiciary Committee members led by ranking member Patrick Leahy (D-VT) introduce a bipartisan amendment to prevent pharmaceutical companies blo...
Two Knobbe Martens attorneys outline reasons why a federal appeals court upheld a lower court jury ruling that a reverse payment to settle patent liti...
CDER deputy director Douglas Throckmorton says FDA is working well with stakeholders to achieve goals on the safe and appropriate use of prescription ...
Office of New Drug associate director Leah Christl says that biosimilar companies should be aware of various regulators requirements when developing t...
In its latest release of Warning Letters, FDA cites Interquim, a Spanish active pharmaceutical ingredient maker.
Federal Register Final Order: FDA classifies Computerized Cognitive Assessment Aids for Concussion into Class II (special controls).