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.
Harvard Medical School researchers call for new incentives to develop antibiotics that show added value for patients through clinical outcomes in pati...
Moderna and Merck say their investigational mRNA cancer vaccine met its endpoint in a Phase 2b melanoma trial.
