WASHINGTON DC (May 24, 2019) — Today, the US Food and Drug Administration (FDA) cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens.

WASHINGTON DC (May 24, 2019) — Today, the US Food and Drug Administration (FDA) permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint-infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.

WASHINGTON DC (April 25, 2019) — The US Food and Drug Administration today announced the launch of a new education campaign to help Americans understand the important role they play in removing and properly disposing of unused prescription-opioids from their homes. This new initiative is part of the FDA’s continued efforts to address the nationwide opioid crisis and aims to help decrease unnecessary exposure to opioids and prevent new addiction.

WASHINGTON DC (April 10, 2019) — Today, the US Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose, or manage head-injury, including concussion, traumatic brain-injury (TBI), or mild TBI.

WASHINGTON DC (April 9, 2019) — The US Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk-factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.

WASHINGTON DC (April 8, 2019) — Today, the US Food and Drug Administration warned against using test-strips from a previous owner (pre-owned) or test-strips not authorized for sale in the US because they may potentially cause infection or lead to inaccurate test results, which can cause serious harm, including death.

WASHINGTON DC (April 3, 2019) — Today, the US Food and Drug Administration announced it is making available online the adverse event reports related to animal drugs and medical devices used in animals. The reports will go back 30 years.

WASHINGTON DC (April 2, 2019) — Today the US Food and Drug Administration announced the issuance of two warning letters to operators of websites that illegally market potentially dangerous, unapproved, and misbranded opioid medications, including tramadol.

WASHINGTON DC (April 2, 2019) — In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD). This interest spans the range of product categories that the agency regulates.

WASHINGTON DC (April 2, 2019) — Access to affordable insulin can be a matter of life and death for Americans with diabetes. Insulin is a critical hormone that regulates sugar metabolism. The body’s inability to produce sufficient levels of natural insulin can lead to diabetes — both inherited Type 1 and Type 2, typically called adult-onset.

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