FDA Law Blog

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

Manufacturing 105

Manufacturing Management IT Medical 105

FDA Law Blog

DECEMBER 4, 2023

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” On October 10th, based on ability to pay, the U.S. 11, 2023 ( DOJ Press Release ). 21 U.S.C. § at 62,341.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

PEMBlog

MAY 1, 2025

Youll also learn how to manage exposures in the emergency department, especially when the child has a pregnant caregiver, and why isolation isnt always necessary once the rash shows up. Well break down the virology, epidemiology, clinical presentation, and complications of Parvovirus B19. So as you can see, this virus does a lot of stuff.

Complication 83

Complication Patient-Centered Patients Diagnosis 83

Common Sense Family Doctor

MAY 11, 2025

A recent article in the BMJ summarized a National Institute for Health and Care Excellence (NICE) guideline on identification and management of gambling-related harms. Although prevalence estimates in North America are low (1.5% of women, 2.7% People with gambling disorder are at increased risk for self-harm and suicide attempts.

Management 52

Management Referral Mental Health Community 52

PEMBlog

JUNE 2, 2025

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. Evaluation consists of lab studies, including CBC, CMP, BNP, troponin, UA, UDS, TSH with reflex to T4, and urine pregnancy test for individuals with a uterus.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed.

IT 40

IT Insurance Government Patients 40