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How to Get Ozempic & GLP-1’s Covered by Insurance (or Save Big with Plum Health Direct Primary Care): The Ultimate Guide You Can’t Afford to Miss!

Plum Health

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. Book a Free In-Person Visit with Plum Health What Is Ozempic, and Why Is It So Popular?

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law

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).

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: (Singing).

IT 102
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

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. By Larry K. They ask for the results of any state inspections. Policies and Procedures.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

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. By Larry K. They ask for the results of any state inspections. Policies and Procedures.

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Are You Recall Ready? FDA Expects You to Be

FDA Law

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. Product coding (e.g.,

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law

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.