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

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. PFI has noted that it is not feasible to develop and label products for an individual state.

Manufacturing 45

Manufacturing Individual Government Illness 45

My Green Doctor

MAY 3, 2025

operating rooms is regulated by the individual states; changing to multi-dose eyedrops will require administrative and legislative advocacy by eye specialists in every state and country. The product manufacturers and vendors will need to be active partners as well. The use of medications in U.S.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

GeriPal

MAY 5, 2022

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. Communication techniques we can use when talking to individuals with hearing loss. But individuals who have hearing loss, there’s several problems. It’s amazing.

IT 102

IT Screening Hospital Clinic 102

FDA Law

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

Government 64

Government IT Manufacturing Illness 64

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We’re going to be talking about new research in psilocybin in serious illness. Margaret 22:45 So the eligibility was that they had to have a life threatening illness.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2022

Then listen to these prior podcasts with Sean Morrison and Rebecca Sudore about this issue, and we recently discussed differences between Advance Care Planning and Serious Illness Communication with Juliet Jacobsen and Rachelle Bernacki. . Where does POLST fit in with this debate? This is Eric Widera. Alex: This is Alex Smith.

Illness 72

Illness IT Healthcare Patient-Centered 72