Topic Archives: Biotech

March 17, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, United States

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

By: Keunbong (KB) Do and Bethany J. Hills

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 …›

March 11, 2020 - Biotech, COVID-19, Healthcare, Medical Devices + Diagnostics, Pharma, United States

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

By: Tina D. Reynolds and Bethany J. Hills

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 …›

January 23, 2020 - Biotech, FDA, Healthcare, Pharma, Regulatory, United States

FDA and Real-World Evidence in 2019

By: Keunbong (KB) Do and Bethany J. Hills

Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The …›

January 9, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 2)

By: Hilary R. Hoffman and Bethany J. Hills

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 …›

September 4, 2019 - Biotech, Intellectual Property, Litigation, Pharma, United States

Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel

By: Janet Xiao and Meghan McLean Poon

In a recent decision, Ajinomoto v. ITC, the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by the …›