We all know that childhood is full of bumps, bruises, and yes—sometimes concussions. A tumble off a bike, a collision on the soccer field—it happens. But what if those head injuries, even the “mild” ones, could echo into your...more
Humans possess several well-established bodily systems, including the sympathetic nervous system, the central nervous system, and the endocrine system. A relatively recent discovery is the endocannabinoid system (ECS)....more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more
When a child suffers harm due to medical negligence, the emotional toll on families can be overwhelming. Parents trust healthcare providers to deliver care that protects and nurtures their child’s well-being. When they make...more
U.S. President Biden signed a bill last Thursday postponing the sunset date of the rare pediatric disease Priority Review Voucher (PRV) program from September 30, 2024, to December 20, 2024. The bill, the “Continuing...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
In July 2023, US Senators Michael Bennet (D-CO) and Chuck Grassley (R-IA), along with US Representatives Lori Trahan (D-MA) and Mariannette Miller-Meeks (R-IA), introduced legislation to improve access to critical care for...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
In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes. In the fifth episode of Sheppard Mullin’s Health-e Law Podcast, Craig...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
Healthcare systems are facing significant challenges in recruiting and retaining talent within the burgeoning field of behavioral health services, primarily due to competition from telehealth providers and inconsistent...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that would come into play upon...more
Since the onset of the COVID-19 pandemic, children have experienced an unprecedented mental health crisis. In response, President Biden has prioritized strengthening and expanding the Pediatric Mental Health Care Access...more
The coronavirus pandemic stubbornly persists, infecting 110,000 Americans daily - and likely many, many more - and hospitalizing 29,000 a day on average. Vaccinations, also, have stayed at the forefront of efforts to...more
While the nation’s pediatricians have announced an important, high-minded goal of eliminating racial bias in the medical treatment of children, working parents and other full-time caregivers for kids need a different kind of...more
In defending pediatric traumatic brain injury cases, defense experts often allege that the pediatric TBI survivor did not sustain any permanent injuries based on the antiquated philosophy that due to neuroplasticity...more
In October there was a local case where parents were in conflict over vaccination of an incapacitated adult child. In that case, Matter of A.C.G., after an evidentiary hearing, the Court ruled that the child could be...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more
The Pfizer-BioNTech COVID-19 vaccine has been authorized by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) for administration to children aged 5-11 years old. ...more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
Compliance Today (March 2021) - According to a recent U.S. Department of Justice news release, Yvelice Villaman Bencosme, a Miami, Florida, doctor and the primary investigator for clinical trials designed to investigate...more
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more
On January 8, 2021, the Department of Justice announced that a Miami, Florida pediatrician pleaded guilty to one count of wire fraud in connection with a clinical research study of an asthma medication for children. ...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