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
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....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
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...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
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The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
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
As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and...more
HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more
In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more
The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more
Earlier this month, Rare Genomics Institute, an international non-profit that makes cutting edge research technologies of genome sequencing, physicians and scientists around the world accessible to rare disease patients,...more