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FDA issues warning letters to website operators for illegally selling opioids online

The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act.

10 Sep 2020

New data reveals overall decline in e-cigarette use, alarming uptick in use of disposable products by youth

Today, the U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey, which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019.

9 Sep 2020

FDA publishes guidance on control of nitrosamine impurities in drugs

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients.

1 Sep 2020

FDA approves a hybrid closed loop diabetes management device for young pediatric patients

Today, the U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes.

31 Aug 2020

FDA announces public meeting to discuss development and licensure of COVID-19 vaccines

The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on CutOct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.

29 Aug 2020

FDA continues to take action in the ongoing response to COVID-19 pandemic

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic

28 Aug 2020

FDA warns consumers about alcohol-based hand sanitizers packaged in containers

The U.S. Food and Drug Administration (FDA) is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.

27 Aug 2020

New COVID-19 antigen test can be directly read from the testing card

Today, the U.S. Food and Drug Administration issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.

27 Aug 2020

FDA provides update on adverse events associated with breast implants

Today, the U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants.

20 Aug 2020

Biotechnological production of a natural antibiotic

Thomas Brück saw the sea whip Antillogorgia elisabethae for the first time 17 years ago while diving on a research trip to the Bahamas.

17 Aug 2020

FDA approves drug for treatment of neuromyelitis optica spectrum disorder

The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody - patients who are anti-aquaporin-4 or AQP4 antibody-positive.

17 Aug 2020

FDA grants emergency use authorization to Yale's SalivaDirect COVID-19 diagnostic test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection.

15 Aug 2020

FDA provides investigation update on Cyclospora illnesses tied to bagged salad consumption

Today, the U.S. Food and Drug Administration is providing an update on the status of the investigation of Cyclospora cayetanensis illnesses tied to the consumption of bagged salads.

15 Aug 2020

FDA approves new treatment option for patients with rare Duchenne muscular dystrophy mutation

Today, the U.S. Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

12 Aug 2020

FDA issues final rule to establish compliance requirements for fermented and hydrolyzed foods

Today, the U.S. Food and Drug Administration issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the "gluten-free" claim. The rule pertains to foods such as soy sauce, yogurt, sauerkraut, pickles, cheese and green olives.

12 Aug 2020

FDA approves opioid agonist for management of moderate to severe acute pain in adults

Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.

9 Aug 2020

FDA approves first companion diagnostic that uses liquid biopsy and NGS technology

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).

7 Aug 2020