FDA Inspires Modifications and Quick Authorizations for Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Read our Class Dismissed …›

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical …›

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health …›

U.S. government announces new federal funding opportunities related to COVID-19

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding to companies …›

2019 FDA Enforcement and Related Litigation Trends (Part 2)

Yesterday, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published press releases about …›

Reflecting on the Challenges and Opportunities of Data at the Hitachi Social Innovation Forum 2019

Are companies keeping up with technological advances, and what are they doing specifically to contribute to society and provide value? What are the future prospects, and what kind of opportunities are being created for progress, including in the digital and scientific arenas? As Japanese companies …›

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) …›