Vascular Physician

APRIL 22, 2024

Unless they are seeing their primary care provider for regular check-ups, they may not be made aware of their high blood pressure until they present for evaluation for another medical condition. Unfortunately, high blood pressure does not always present with symptoms that are noticeable by the patient.

ER 52

ER Hypertension Primary Care Medical 52

FDA Law Blog

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. At an October 2019 Meeting , FDA explained the application process and provided assurances that decisions would be made on each specific product in a submission—not the submission in its entirety.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Instead, it was GSK who erred in omitting the post-MI language from the use code.

IT 52

IT Provider ER Insurance 52