Articles and Blogs

Sunday, March 22 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website.​ Congressional Outlook A procedural vote to end debate and move to a... READ MORE

Saturday, March 21 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website.​ Congressional Outlook After 12 hours of negotiation on Friday, Republicans and Democrats... READ MORE

Thursday, March 19 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website. Congressional Outlook Senate Republicans released the attached proposal for the third COVID-19... READ MORE

On March 18, 2020, the FDA issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic that provides guidance for Sponsors, Clinical Investigators and Institutional Review Boards (“IRBs”) on how to address disruptions in the conduct of clinical trials (“Trials”) as a result of COVID-19. COVID-19 Disruptions to Clinical Trials... READ MORE

Wednesday, March 18 Update Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website. Congressional Outlook Sen. Mitch McConnell (R-KY) reversed course and the Senate passed... READ MORE

Pharmacogenetic Testing and the FDA’s 2018 Warning The advent of direct-to-consumer genetic testing has yielded an explosion in the development of various types of genetic tests for clinical treatment and diagnostic purposes. These tests include pharmacogenetic tests, which are used to better understand the role genetics play in an individual patient’s reaction to certain... READ MORE

It is no secret why the novel coronavirus (“2019-nCoV”) outbreak in Wuhan City, Hubei Province, China quickly raised health concerns on an international scale. The coronavirus family contains member viruses with a similarly sinister and deadly past; viruses that seemingly appeared out of nowhere and rapidly spread. For example, two betacoronaviruses were the culprits... READ MORE

The USDA Hemp Producer License Rule and Framework On October 31, 2019, the United States Department of Agriculture (“USDA”) published an interim final rule[1] with request for comments in the Federal Register regarding hemp production (“USDA Hemp Rule” or the “Interim Final Rule”).[2] The USDA Hemp Rule establishes a federal hemp producer license and... READ MORE

The centuries-old practice of homeopathic medicine, which has been the subject of much controversy and debate for nearly the entire length of its existence, may finally be going to the mat with the Food & Drug Administration (“FDA”). Amidst growth in the homeopathic products industry and associated concerns with their safety, efficacy and quality,... READ MORE

It isn’t only the U.S. Food & Drug Administration (“FDA”) and Drug Enforcement Agency (“DEA”) that are interested in all things cannabis. Today, the FDA followed earlier warning letters[1] by posting yet another press release regarding an October 10, 2019 warning letter that was issued jointly by the FDA and the Federal Trade Commission... READ MORE