The reissued EUA allows for fingerstick blood samples to be tested in point-of-care settings.
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
The unapproved and misbranded opioids, which include tramadol and oxycodone, are being sold without a prescription.
Phexxi (lactic acid, citric acid and potassium bitartrate; Evofem Biosciences) is the first non-hormonal, on-demand contraceptive vaginal gel.
The FDA reported that between July 27, 2016 and July 27, 2020, a total of 107,728 medical device reports (MDRs) associated with SCS devices intended for pain were received.
The outpatient procedure provides noninvasive magnetic stimulation to areas of the brain known to be associated with addiction.
Hydrochlorothiazide is indicated for the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives.
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
HHS issued the amendment in order to increase access to childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children return to daycare and school.
This is the first FDA-approved therapeutically equivalent, substitutable generic of Tecfidera.
