USFDA

The U.S. Food and Drug Administration permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.

The  number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017.  This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.

The U.S. Food and Drug Administration approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

The U.S. Food and Drug Administration approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.

Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. FDA is taking steps on two additional device programs: finalizing guidance on our existing Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy. Our goal is to ensure that the benefits and risks are clearly articulated in drug labeling. That patients and providers have accurate information. And that the benefits outweigh the risks for the intended patient population.

Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more complex. Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges.

The bedrock of our mission is our consumer protection role – our obligation to protect patient safety. Part of our mission also inspires us to promote beneficial innovations that can advance patient care.