Barton Associates
JUNE 19, 2025
There’s a lot that goes into running a healthcare facility , from managing patient care to ensuring adequate coverage around the clock. In these complex and ever-changing environments, staffing challenges can quickly become a critical issue, impacting both patient care quality and operational efficiency.
FDA Law
SEPTEMBER 30, 2022
Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). This is evidence of FDA’s embrace of patient-focused drug development. By Frank J. Sasinowski & James E.
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FDA Law
JULY 11, 2023
As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.” To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy.
FDA Law
AUGUST 18, 2024
The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.
Physician's Weekly
JUNE 19, 2025
On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.
GeriPal
JULY 28, 2022
Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families.
Georgetown Pediatrics & Family Medicine
FEBRUARY 7, 2022
I tried hard to be accessible to patients and to make them unafraid of me so we could have free and open conversations,” said Dr. Canady. “We We also tried to arrange the patient care considering the needs of the families.” Canady is now enjoying retirement in Pensacola, FL. “I
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