Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more
California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...more
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) is planning to hold floor votes on unemployment benefits forcing Democrats to go on the record as coronavirus relief bill talks stall. Floor votes are a...more
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
Report on Research Compliance 17, no. 8 (August 2020) - Higher education groups and others are hailing a decision by the administration to rescind planned rules that would have required students in the United States on...more
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more
Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential...more
CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more
A poet from West London once wrote, "Meet the new boss, same as the old boss," a frustrated statement lamenting that the status quo in any system tends to prevail despite calls for revolution. If one judges the potential for...more