FDA Law Blog

APRIL 6, 2025

For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.

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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. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

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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

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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. §

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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. In this case, the Supreme Court provided greater clarity on how to interpret that requirement.

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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. § That statute provides that courts “ shall have jurisdiction, for cause shown, to restrain violations ” of the FDC Act. By JP Ellison & John W.M. N atural Resources Defense Council, Inc.

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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. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

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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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. §

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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. or Canada to become eligible for ABIM Board Certification.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

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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. Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting. Siddharta G.

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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. government in the now-infamous (at least in FDA circles) Teva v.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. surgical robots, MRIs)?

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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. So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. So sometimes I don’t write.

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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. Radical Transparency. The RFI is not all bad news and irony, though.

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