Coronavirus (COVID-19) Update: July 23, 2021

Coronavirus (COVID-19) Update: July 20, 2021

Coronavirus (COVID-19) Update

The FDA fully approved a drug intended to treat lymphoma in dogs, making the drug the first conditionally approved new animal drug for dogs to achieve full FDA approval.

Coronavirus (COVID-19) Update: July 13, 2021

Coronavirus (COVID-19) Update: July 9, 2021

Joint CDC and FDA Statement on Vaccine Boosters

This draft guidance explains how the agency plans to adjust its regulatory oversight activities for foods subject to FDA regulatory requirements when the foods are produced in or imported from other countries.

Coronavirus (COVID-19) Update: July 6, 2021

Coronavirus (COVID-19) Update

As part of our ongoing efforts to combat foodborne illness, the FDA released the Cyclospora Prevention, Response and Research Action Plan

The FDA approved a drug as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.

FDA announced it is revoking EUAs of all non-NIOSH-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems.

FDA Provides Update on Ongoing Efforts to Better Understand the Occurrence of PFAS in the Food Supply

The FDA has sent to Congress its Report on Drug Shortages for Calendar Year 2020, which includes a section on the agency’s drug shortage efforts in response to COVID-19. The FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, & Economic Security Act.

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FDA released new draft guidance encouraging broadening clinical trials eligibility criteria to include patients with incurable cancers, regardless of prior therapies.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