FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. Nevertheless, the Agency believes this bifurcated system presents public health risks, and needs to be corrected by bringing LDTs under the FDA’s general IVD regulatory framework.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 120

IT Patient-Centered Patients Clinic 120

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

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms?

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Further, information presented on the adverse reaction data was inconsistent with the PI.

Vaccination 64

Vaccination IT Manufacturing Screening 64