FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

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FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. By Jeffrey K.

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FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Interpretation of Statutory Criteria Under the Final Guidance.

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FDA Law Blog

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. HB 86 – Rural Hospital Investment Fund Bill What’s in the Bill: Sponsored by Rep.

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP.

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

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GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. J Am Geriatr Soc. Welcome to the GeriPal podcast, Nisha. Nisha: Thank you so much. Happy to be here. Tasce: Thank you.

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FDA Law Blog

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction.

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GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management.

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GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. What do we do to very concretely provide heat shelters and cool shelters? And there are so many things that can be done to address climate change.

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FDA Law Blog

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

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Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. We were so nervous about not being on a company-provided plan,” Winard said. It also covers 80% of the cost of drugs provided in an outpatient setting. Then the bill came.

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FDA Law Blog

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.

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