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Sponsors of CDER-led drug-device combination products that include electronics or software should include specific technical information in their Type V drug master files, the FDA said in a draft guidance released on Monday. Read More
The facilities will be selected based on priorities identified for staff training, the facility’s compliance status, and on consultation with the FDA district office. Read More
The institute endorsed the medicine for patients with a high risk of atherothrombotic events if they are not at an increased risk for bleeding. Read More
The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read More
In a joint statement, acting FDA Commissioner Ned Sharpless and CDER Director Janet Woodcock announced that the agency is changing its approach to regulating homeopathic drug products that pose significant risks to patients. Read More