FDA Law Blog

FEBRUARY 18, 2025

While on paper the respective credentials of each of the experts would indicate a balance of authority, or maybe even weigh in favor of the pharmacys expert (DEAs expert had prior disciplinary history), the ALJ and DEA Administrator each found the testimony of the governments expert more credible. Whats the take away?

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

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FDA Law Blog

MAY 4, 2025

1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China.

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FDA Law Blog

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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FDA Law Blog

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery.

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FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Medicare or Medicaid). OIG reviews non-safe harbored arrangements on a case-by-case basis. In contrast to its decision in United States v. Polin , 194 F.3d 3d 863 (7th Cir.

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FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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FDA Law Blog

SEPTEMBER 30, 2022

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates. of America v.

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FDA Law Blog

JULY 2, 2024

Claud — Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § While she agreed with the decision here, she did not join in the Court’s decision that the traditional pillars of equity apply in all cases where a special statute provides for injunctive relief.

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FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. DEA regulations require “adequate security” but do not specially require cameras in health care facilities. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36

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ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. Erin Bonura, MD, Chair, ABIM Infectious Disease Board The Infectious Disease Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on March 25, 2025.

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FDA Law Blog

MAY 11, 2023

Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. government in the now-infamous (at least in FDA circles) Teva v. Plainly, the Government brief states “The decision below is incorrect.

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ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. The following is a summary of the spring meeting. Rodriguez, MD , Chair of the Nephrology Board, and John C. Siddharta G.

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FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. How do you find time to write and also be doctors and academic professors? In all seriousness, you don’t actually have to want to write a book to be interested in this podcast. Welcome to the GeriPal podcast, Rosanne. And I loved it.

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FDA Law Blog

JUNE 21, 2022

This provision adds nothing substantive to the OTC hearing aid regulatory scheme—it merely tells FDA that it has 30 days from enactment of the user fee legislation to issue its final rules governing OTC hearing aids. Directing FDA to issue rules isn’t out of the ordinary.

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FDA Law Blog

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. The Announcement raises several questions and issues for the device industry.

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