Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Hosted Payload Episode 9: Danielle Pineres/First Man
[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1
What to Do When Your University, FBI, or DOJ Knocks on Your Door: Responding to University, Criminal, and Civil Investigations
Chien-Shiung Wu - The First Lady of Physics (Women's History Month)
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more
The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
With the advancement in modern medicine, people are living longer than ever. In fact, the average life expectancy has largely risen over the last 40 years, and is predicted to rise to 85 by the year 2060 (US Census:...more
Readers of this newsletter know we’re big fans of high-quality medical research. Well-designed, statistically robust studies have saved lives, changed medical practice, and made the world a better place....more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more
The domestic cat has been the subject of much study, recently involving its genetic structure, genomic DNA sequence, and comparisons with other felines. The first such study was published in 2014, when an international...more
Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more
Key Points - Notice reflects NIH’s continued concerns regarding foreign influence and imposes significant new compliance obligations on both grantees and individual researchers. - Obligates grantees to provide NIH...more
It is a bold and almost frightening conjecture that “most published research findings are false.” In the current COVID-19 era, most of us have noticed an uptick in the popular prevalence of published scientific and medical...more
As we have all heard, the gastrointestinal tract (gut) is full of numerous types of bacteria. Some are helpful, some are harmful. For those of us who take probiotics and/or eat fermented foods, we know that we are working...more
No painful procedure or biopsy needed. We can test our blood to diagnose and even predict cancer. The Human Genome Project, a joint effort between the U.S. Department of Energy and the National Institutes of Health, began...more
There are an estimated 219 million cases of malaria per year, leading to more than 400,000 deaths annually according to the World Health Organization. Hemocytes (insect white blood cells) comprise the mosquito immune system...more
Will it be a shot in the arm — or the foot? Americans have invested high hopes in a Covid-19 vaccine. Its development is racing ahead, with researchers deploying novel approaches and governments spending billions of dollars...more
Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more
Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more
As the COVID-19 pandemic has disrupted life throughout the world this spring, bats have been a prominent feature in news stories and recriminations about how the pandemic started (and being blamed even more than happenings in...more
Report on Research Compliance 17, no. 2 (January 23, 2020) - - More than two years after Ozgur Tataroglu’s paper was retracted, the HHS Office of Research Integrity found that it and two grant applications contained...more