In December 2021, FDA issued draft guidance, Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations, which provides guidance for clinical trial sponsors, investigators and other interested...more
Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections.
Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more
The U.S. Food and Drug Administration (FDA) issued an update to its guidance document, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,”...more
In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more
On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...more
In a June 6 Letter of Authorization (LoA) regarding the emergency use authorization (EUA) for non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators manufactured...more
On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by...more
Medical supply shortages have been in the limelight since COVID-19 barreled into the U.S. and many manufacturers have been doing all they can to answer the call for more supplies. In response to this issue and recently passed...more
In a May 7 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its April 3 LoA with revised eligibility EUA criteria for non-NIOSH-approved disposable filtering facepiece respirators...more
On April 18, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for face masks in its continuing effort to address shortages of the personal protective equipment (PPE). This most recent...more
The Food and Drug Administration (FDA) issued on April 9, 2020 its first emergency use authorization (EUA) for face shields to address the significant shortage of personal protective equipment (PPE) during the COVID-19...more
On April 5, 2020, the U.S. Food and Drug Administration (FDA) issued guidance about its “Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...more
On April 4, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance on “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...more
On April 3, 2020, the Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China. This EUA supplements the...more
On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the...more
The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more
The Society of Critical Care Medicine estimates that the United States has over 200,000 ventilators, although other organizations have lower estimates. ...more