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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. Everything You Need to Know About Costs and Coverage Patient is inquiring about healthcare.

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

FDA Law Blog

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

FDA Law Blog

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.

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

FDA Law Blog

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.

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Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. Almost all recalls are conducted on a voluntary basis by the manufacturer. The Guidance emphasizes that firms need to be “recall ready.”

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

GeriPal

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And one of the parts of that was actually doing physicals for the students and putting them in job placements. So this is a podcast going at the geriatricians and palliative care providers. Hearing aids, you had six big manufacturers of hearing aids.

IT 102
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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

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.