FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as...
CBERs Office of Compliance and Biologics Quality sends an untitled letter to Minneapolis Regenerative Medicine over claims made on the firms Web site....
FDA grants a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on their backs.
Federal Register notice: FDA makes available a draft guidance entitled Infectious Otitis Externa Drugs for Topical Use in Dogs.
FDA finds deficiencies in Ascendis Pharmas NDA for TransCon PTH (palopegteriparatide), indicated for treating hypoparathyroidism.
Federal Register notice: FDA makes available a draft guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan fo...
A JAMA research letter says 54% of accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in meeting their FDA co...
FDA approves an Astellas Pharma BLA for Padcev (enfortumab vedotin-ejfv) for use with Mercks Keytruda in certain patients with locally advanced or met...
