FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine.

Utilities 59

Utilities Manufacturing Provider Individual 59

GeriPal

JUNE 20, 2024

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. Biological aging or physiological aging varies from individual to individual.

IT 120

IT Patient-Centered Patients Clinic 120

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. I’m guessing not. How to screen for hearing loss. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

OCTOBER 16, 2024

Left ventricular ejection fraction (LVEF) is a variable measure, so use clinical judgment in deciding whom to treat.” By leaving intact Bristol-Myers Squibb , notwithstanding the argument that Loper Bright nullifies it, the Court preserved an important avenue for generic drug manufacturers.

Manufacturing 98

Manufacturing Patients IT Hospital 98

FDA Law

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Schedule III substances do not require manufacturing quotas.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95