FDA Law

SEPTEMBER 18, 2024

However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement. By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement.

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FDA Law

JUNE 28, 2021

If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. Manufacturers would still be required to report sales of these products to the Board of Pharmacy, but they would not be factored into the determination of the opiate product registration fee.

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CDOCS

APRIL 14, 2021

& But, I don&rsquo;t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> & & First, you&rsquo;re getting a CEREC system for single unit posteriors.& & Yes, the Primescan is amazing.&

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GeriPal

MAY 5, 2022

If you want to take a deeper dive into this subject and read some of the articles we discussed in the podcast, check out the following: Hearing Loss: Effect on Hospice and Palliative Care Through the Eyes of Practitioners. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. I’m guessing not.

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FDA Law

APRIL 22, 2025

The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show Cause (or OSC) from DEA. The Administrator will then issue a final order based on the review of the evidence and written statements provided. What Is an Order to Show Cause?

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FDA Law

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. Two judges on the D.C.

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FDA Law

DECEMBER 20, 2021

As readers of this blog may know, FDA is not required to provide a substantive response to a CP within a specific time and it may take years before FDA issues a response (In fact, HPM submitted a CP in 2000 to which FDA has yet to respond). It also has been approved and is used to treat acetaminophen poisoning and some other conditions.

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The Health Policy Exchange

MAY 20, 2013

Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. Unfortunately, recent case studies have illustrated that FDA approval does not necessarily provide assurances of effectiveness and safety. Approval from the U.S. Could the FDA and other U.S.

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GeriPal

MARCH 2, 2023

I could go on and on, but listen to the podcast instead and for a deeper dive, take a look at the following articles and studies: Gabapentin in the Perioperative setting: Prolonged use of newly prescribed gabapentin after surgery. By 2015 that number increased to 4% of US adults. J Am Geriatr Soc. Tasce: I do. Tasce: Yes. Taylor Swift.

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GeriPal

MAY 8, 2025

And it kind of made its way into medicine probably around, I’m going to say the 50s after there was a fairly interesting Time Life article that was published. And when that article went to print, it just went ballistic. I’m actually going to show you a picture of the green doors just so you can see it. It’s there.

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GeriPal

MARCH 24, 2022

Start by reading this article by Sean Morrison, Diane Meier, and Bob Arnold in JAMA , and this response from Rebecca Sudore, Susan Hickman, and Anne Walling. This is the latest in our series of podcasts on concerns about, and potential of advance care planning. If you’re new to this discussion, don’t start with this podcast! Here we go.

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Illness IT Healthcare Patient-Centered 72

FDA Law

JANUARY 3, 2024

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). And CVM certainly exercises that authority.

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GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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FDA Law

MAY 12, 2025

Kirschenbaum On September 15, 2020, I posted an article in this blog entitled Trump Embraces International Reference Pricing in Executive Order, which described an order in Trumps first administration to use most-favored-nation (MFN) pricing as a limit on Medicare payment. Within 30 days (i.e., Within 30 days (i.e., Within 180 days (i.e.,

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FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Court of Appeals (again, see our post ).

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