Federal Register Notice: FDA co-sponsors with Xavier University a public conference entitled FDA/Xavier University Medical Device Conference.
FDA clears a VivaLnk 510(k) for the Fever Scout, a soft, wearable thermometer that continuously measures a persons temperature.
Amgen files a supplemental BLA for Xgeva (denosumab) to expand its use for preventing skeletal-related events in solid tumors to include patients with...
FDA warns clinical investigator Cassandra Curtis about violations in a Pfizer Chantix study.
FDA publishes a list of 11 drugs or classes of drugs for which potential signals of serious risks/new safety information were identified in the 4th qu...
FDA biomarker development program co-director Chris Leptak describes three sources of biomarker information FDA can use in regulatory decisions.
Dr. Reddys Laboratories says an FDA-483 raised two new concerns with its Srikakulam API facility.
FDA releases its latest batch of Warning Letters that cite Cassandra E. Curtis, Sanapac Co., and Trone Health Services.