FDA Law

MARCH 9, 2025

The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, and new FTC advertising guidelines.

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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.

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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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Hospital Manufacturing Specialization Medical 52

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. FDA provided an interim response to the citizen petition 180 days after the petition was filed, stating that due to competing agency priorities FDA had not reached a decision on the citizen petition.

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Physician's Practice

JUNE 9, 2025

**Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Reynolds Published: June 2nd 2025 | Updated: June 2nd 2025 Article Your weekly dose of wisdom from the Physicians Practice experts. Singer, M.D.

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Management Telemedicine Patients Insurance 52

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 Immediate Suspension Order?

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Government Provider Consulting Manufacturing 52

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> .& I would wager that anyone that has used the Primescan would never give it back for their Omnicam or Bluecam.&

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IT Patients Provider Appointment 52

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.

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Manufacturing Government Medical IT 40

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). FDA merely indicated that it was still considering that issue.

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IT Manufacturing Education Provider 52

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. Five big manufacturers.

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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. J Am Geriatr Soc. 2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM.

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Patient-Centered IT Healthcare Medical 96

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. And CVM certainly exercises that authority. In late2023, CVM issued nine Warning Letters to distributors of veterinary products for use in aquarium fish and birds.

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Manufacturing Education Patient-Centered Vaccination 59

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. Some of them also had psychiatric or psychosocial oncology providers as well. Gordon Alwasa.

Illness 107

Illness IT Patient-Centered Patients 107

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. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. Eric: Susan. Susan: Yeah.

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Illness IT Healthcare Patient-Centered 72

GeriPal

DECEMBER 7, 2023

And on that, I found a link to this article by Rick Moody called Elders in Climate Change, No Excuses, in which he argues that elders are the group that benefited most from the massive consumption of fossil fuels in the post World War II eras. What do we do to very concretely provide heat shelters and cool shelters?

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Healthcare IT Education Hospital 129

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 180 days (i.e.,

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Manufacturing Provider Patients IT 77

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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Manufacturing Supply Chain Patient-Centered Utilities 98