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 f
February FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and produ
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)
FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)
FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including
FDA Working to Address 2019 Novel Coronavirus (COVID-19): Product Safety (Part I)
FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including
January FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and produ
New USPTO Rule Likely to Increase Spam
The United States Patent and Trademark Office (USPTO) just issued new rules that directly affect trademark owners. Going forward, trademark applicants, registr
FDA and Real-World Evidence in 2019
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 ag
Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants
On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to
Digital Health in 2019
The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) address