Federal Register notice: FDA renews for two years the charter of its Cardiovascular and Renal Drugs Advisory Committee.
Federal Register notice: FDA sends to OMB an information collection revision entitled General Drug Labeling Provisions and OTC Monograph Drug User Fee...
CDER and CBER release a $2.25 million funding opportunity announcement to assess the potential utility of real-world data to generate real-world evide...
FDA warns Indias Centrient Pharmaceuticals about significant CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Researchers conclude clinicians are challenged to interpret results from both Bayesian and traditional statistical outputs from clinical trials and ne...
Attorney Jeffrey Shapiro says FDA appears to be trying to get LASIK laser manufacturers who have an approved PMA to submit a supplement for new patien...
Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) introduce HR 9487, Advancing Safe Medications for Moms and ...
A Brookings Institution report suggests ways to speed FDA therapeutic equivalence ratings for injectable drugs approved through the 505(b)(2) process.
