The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA said it instructed Novartis to place a new warning on labeling for its multiple sclerosis treatment Gilenya (fingolimod) and the agency issued a warning that abruptly ending treatment can severely exacerbate the disease. Read More
The review will assess the levels of NDMA in the valsartan drugs, the possible impact on patients that have been taking them and actions that can be taken to reduce or eliminate the impurity from future batches. Read More
Keytruda’s new indication is for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Read More