USA – BARDA opens research portal to combat COVID-19 pandemic

The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness...

USA – What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of...

As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus...

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including...
New guidance on biologics affects authorized generics

USA – Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease...

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious...
New guidance on biologics affects authorized generics

USA – FDA Lifts Requirements for Masks, Respirators, Looks to Reprocessing to Ease Shortages

As the supply of critical personal protective equipment (PPE) dwindles amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) is...
New guidance on biologics affects authorized generics

USA – COVID-19 Response: What manufacturers should know about US FDA Emergency Use Authorizations...

As US healthcare providers face shortages of medical devices and equipment during the COVID-19 pandemic, the Food and Drug Administration has moved to expedite...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA Eases Import Requirements for Devices and PPE to Fight Coronavirus

To increase the availability of personal protective equipment (PPE) and other medical devices amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug...
New guidance on biologics affects authorized generics

USA – FDA urges device companies to report shortages

The FDA tweeted a request to medical devicemakers to report any potential shortages of equipment that may be necessary to diagnose COVID-19, since they...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic

The US Food and Drug Administration (FDA) released guidance on Friday saying it does not intend to object to limited modifications to the indications,...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the...

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus...