Food and Drug Administration

Coronavirus (COVID-19) Update

The FDA authorized a drug for the treatment for the treatment of COVID-19 in hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

FDA released new draft guidance encouraging broadening clinical trials eligibility criteria to include patients with incurable cancers, regardless of prior therapies.

The FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger; and issued a warning letter to a company selling an unapproved product

Today, the FDA approved Pradaxa oral pellets and capsules to treat children with blood clots directly after they have been treated with a blood thinner given by injection for at least five days, and to prevent recurrent clots among patients who completed treatment for their first clot.

FDA approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch.

The FDA qualified a medical device development tool to help assess individuals’ symptoms and satisfaction with vision associated with LASIK surgery.

The draft guidance should clarify “remanufacturing” and recommendations for labeling devices intended to be serviced over their useful life. A discussion paper outlining cybersecurity challenges and opportunities with the servicing was also released.

Coronavirus (COVID-19) Update: June 15, 2021

FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns).

Coronavirus (COVID-19) Update: June 11, 2021

FDA authorized two batches of Janssen’s COVID-19 vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore

The FDA issued draft guidance to address which patient-reported outcomes concepts to measure in cancer clinical trials.

Coronavirus (COVID-19) Update: June 8, 2021

The FDA approved a drug for the treatment of Alzheimer’s under the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides meaningful therapeutic advantage over existing treatments.

FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with type 1 plasminogen deficiency, also referred to as hypoplasminogenemia.

Coronavirus (COVID-19) Update: June 4, 2021

FDA approves Wegovy (semaglutide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition.

FDA provides guidance to help ensure that prescription drugs are identified and traced properly as they move through the supply chain.

FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System.