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. With Plum Health, managing your diabetes becomes easier, more affordable, and less stressful.

Primary Care 52

Primary Care Insurance Diabetes Manufacturing 52

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

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. Firms also need to maintain distribution records to facilitate identifying the direct accounts that received the recalled product by name, physical address where the product was delivered, and contact information.

Electronics 40

Electronics Manufacturing Provider IT 40

GeriPal

MAY 5, 2022

And one of the parts of that was actually doing physicals for the students and putting them in job placements. And so often we get consulted by teams that say, “I have this older patient and they’re pretty isolated and I think they have dementia. Hearing aids, you had six big manufacturers of hearing aids.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

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