FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” 2011), here , and United States v. Borrasi, 639 F.3d

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management 52

Management Manufacturing Specialization IT 52

FDA Law Blog

JULY 24, 2023

Specifically, FDA determined that Avadel’s Lumryz can “break” Jazz’s ODE because it is “clinically superior” based on Lumryz’s “major contribution to patient care,” rendering it not “the same drug” under the Orphan Drug Act. Avadel has intervened as a Defendant, and neither FDA nor Avadel has yet to respond to the Complaint.

Clinic 52

Clinic Provider IT Patients 52

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. But technical limitations have made it hard to understand how neurons in this area form functional circuits."

Provider 109

Provider Medical Complication Diabetes 109

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? We’ll talk about is it in medical practice yet? Eric: You’ve timed it perfectly. It came after engaging her.

IT 99

IT Community Patient-Centered Medical 99