Updating the Research Compliance Handbook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast - Discussing the Mission of Black Women's Health Imperative with CEO Linda Goler Blount
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
BLACK HISTORY MONTH | KATHERINE JOHNSON AND CHARLES DREW
Technology in Healthcare
Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more
Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...more
A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...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 the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
What consumers can do to reduce environmental health threats all around us - It’s a paradox of modern life: We want more and more stuff, and we want to get all of it faster, cheaper, more conveniently. And yet, does our...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
On July 14, 2023, the World Health Organization (WHO) published a summary of two findings regarding aspartame, an artificial sweetener found in many consumer products. One finding categorized aspartame as “possibly...more
On 3 May 2022, the European Commission launched its proposal for a Regulation for the European Health Data Space to “unleash the full potential of health data”. However, questions arise as to whether this proposal is a...more
Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...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
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
Recently the United States Patent and Trademark Office (USPTO) announced a new prioritized examination program for trademark and service mark applications meeting certain requirements. The program allows applicants to...more
As reported by the National Animal Interest Alliance (NAIA), bill – H.R.6921 (the Healthy Dog Importation Act) – has been introduced in Congress that would require proper health screening of dogs imported into the United...more
The United States built a rigorous system over decades to protect patients from harm while receiving new types of medical treatment. New drugs and new vaccines, in particular, have been barred from widespread use until they...more
This content was originally published on April 15, 2020. It was last updated as of Saturday, May 2, 2020 at 8:00 a.m. CST. American universities, hospitals, and other institutions currently have a wide variety of...more
This content was originally published on April 15, 2020. It was last updated as of Tuesday, April 21, 2020 at 5:00 p.m. CST. American universities, hospitals, and other institutions currently have a wide variety of...more
Nowadays the sphere of healthcare is becoming one of the mostly discussed because of a mass spread of the coronavirus pandemic (also COVID-19). Confirmed cases of COVID-19 around the world have passed more than a 2.4 million....more
American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting...more
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
Despite myths perpetuated by animal activists, animal models remain critical to ensure that vaccines developed to prevent COVID 19 infections do not make those patients worse as a result of such treatment, as Dr. Fauci...more
Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at...more