FDA Law

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., for multiple violations observed during an inspection that occurred eight months ago. To be sure, this is not the first time that FDA has included the “Limiting Photography” observation in a Warning Letter.

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FDA Law

OCTOBER 19, 2021

FTC was pending before the Supreme Court, former Federal Trade Commission (FTC) Commissioner Rohit Chopra (now Director of the Consumer Financial Protection Bureau) and Samuel Levine (recently appointed Director of the FTC’s Bureau of Consumer Protection) coauthored an article proposing resurrecting the FTC Act’s penalty offense authority.

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FDA Law

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

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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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FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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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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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. Think about the last time you attended a talk on communication skills or goals of care discussions. I’m guessing not.

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FDA Law

OCTOBER 14, 2024

Regulatory Background FDA regulates and generally requires premarket approval of all new drugs, which are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” 21 U.S.C. § Robbins , 519 U.S. Wilkie , 588 U.S.

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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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FDA Law

FEBRUARY 27, 2023

This error has appeared not just in articles and other news publications but in some court documents as well. Gilbert — One misnomer that has been repeated over the years has been the reference to the “Drug Enforcement Administration” (“DEA”) as the “Drug Enforcement Agency.” The DEA has even made the same mistake.

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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 21, 2021

In other words, the California law assumes that every potential Paragraph IV patent settlement is anticompetitive, and the pharmaceutical manufacturers must show that the settlement is not anticompetitive to avoid upwards of $20 million in fines. The case was dismissed without prejudice. Actavis , 510 U.S.

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FDA Law

DECEMBER 20, 2021

NPA asks the court to declare that the exclusionary clause does not retroactively apply to the dietary supplement NAC and seeks a preliminary and permanent injunction prohibiting FDA from taking any regulatory action against manufacturers, sellers or distributors of NAC based on the claim that the drug exclusion prohibition is retroactive.

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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. Hull We published a version of this post several years back (see here ), but recent updates to the law and trends in DEA enforcement merit a refresher.

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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. In the meantime, lobbyists working for the drug manufacturers successfully blocked efforts by Medicare administrators to stop paying for the higher (harmful) doses. Approval from the 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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FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. As we chronicle in an article that appears in the current edition of the Food and Drug Law Journal , FDA’s policies for reviewing COVID assays, have been a contributing factor.

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FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. As we chronicle in an article that appears in the current edition of the Food and Drug Law Journal , FDA’s policies for reviewing COVID assays, have been a contributing factor.

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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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FDA Law

JANUARY 3, 2024

To carry out its mission, CVM has the same enforcement tools that the rest of FDA, like CDER and CDRH, have, including the authority to conduct inspections, issue warning letters, seize products, add manufacturers to import alerts, and impose penalties on bad actors. Enter the FDA’s Center for Veterinary Medicine (“CVM”).

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FDA Law

DECEMBER 21, 2021

In other words, the California law assumes that every potential Paragraph IV patent settlement is anticompetitive, and the pharmaceutical manufacturers must show that the settlement is not anticompetitive to avoid upwards of $20 million in fines. The case was dismissed without prejudice. Actavis , 510 U.S.

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Manufacturing IT 40

FDA Law

FEBRUARY 4, 2025

In 2006, David Ridley, Henry Grabowski, and Jeff Moe proposed a voucher in an article in Health Affairs as an incentive to develop therapies for neglected infectious and parasitic diseases that affect hundreds of millions of people in the developing world. Below, we discuss some of its downstream impacts on the PRV landscape.

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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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Tiny Physician

OCTOBER 17, 2021

In this article, I will explain why this homeopathic remedy shouldn’t be distributed in our schools for children. In case you want to know in detail about the basics of homeopathy, you can check my article on principles of homeopathy given below.

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Physician's Weekly

JULY 3, 2025

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article. The Trump administration has declared that it will aggressively combat chronic disease in America. But the administration is seeking to cut government funding that could serve as a counterweight. Kennedy Jr.

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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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