Plum Health

AUGUST 30, 2024

Update: Click here to book a free 30 minute in-person consultation with Dr. Sharon or Dr. Mike to discuss affordable GLP-1 medication! Managing diabetes—especially as you get older—can be challenging physically, emotionally, and financially. Save with a copay savings card. Save with patient assistance programs.

Primary Care 52

Primary Care Insurance Diabetes Manufacturing 52

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The registrant’s employees together with the investigators conduct a closing physical count of the drugs to be audited.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The registrant’s employees together with the investigators conduct a closing physical count of the drugs to be audited.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law Blog

MARCH 20, 2022

To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. Almost all recalls are conducted on a voluntary basis by the manufacturer.

Electronics 40

Electronics Manufacturing Provider IT 40

GeriPal

MAY 8, 2025

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? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management. So I can say anything I want. So 5ht2 was.

Illness 107

Illness IT Patient-Centered Patients 107