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

My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. Video recordings were taken as providers administered perioperative routine eyedrops to patients and the eye drop bottle tips were cultured to assess microbial growth. The product manufacturers and vendors will need to be active partners as well.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

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.

Individual 45

Individual Manufacturing Government Illness 45

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. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: Great story.

IT 102

IT Screening Hospital Clinic 102

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

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

In 1996, a variant of H5N1 was documented overseas that resulted in a severe illness in birds and was designated as highly pathogenic avian influenza (HPAI). There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130