FDA Law Blog

NOVEMBER 6, 2022

In September 2020, the OIG issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS because one purpose of the program, and perhaps the primary purpose, would be to induce Medicare beneficiaries to purchase Pfizer’s federally reimbursable medication. 2011), here , and United States v.

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

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

FDA Law Blog

JULY 24, 2023

More specific to the facts of this case than the governing statute, Jazz argues that OOPD’s determination that Lumryz is clinically superior to Xywav is inconsistent with FDA’s regulations. Jazz believes that FDA precedent precludes that position and thus FDA departed from established policy, which FDA denied ever existed.

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Clinic Provider IT Patients 52

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

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Eric: Are these generic?

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

APRIL 13, 2023

Julianne: It’s interesting because I think I read somewhere that a finding in science often takes about, on average, 17 years to make it into medical practice. We’ll talk about is it in medical practice yet? She tried to extend conversations beyond what was medically, I think, necessary for the encounter.

IT 99

IT Community Patient-Centered Medical 99