FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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CDOCS

APRIL 14, 2021

& When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & & First, you’re getting a CEREC system for single unit posteriors.&

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PEMBlog

MAY 11, 2023

There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). It has also been shown to increase the likelihood of success.

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FDA Law Blog

AUGUST 12, 2024

The Court pretty quickly determined that “FDA acted arbitrarily and capriciously when applying [the PTE statute] to BRAVECTO because the FDA did not provide fair notice or an adequate explanation of its shift in methodology.” The “review phase” is the period between the initial submission and approval of the NADA. While Nissan et al.

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FDA Law Blog

OCTOBER 4, 2021

Importantly, the orphan drug designation, awarded in 2009, had been for LEMS generally—not LEMS in adults. Reviewing the decision de novo , the Eleventh Circuit determined that the definition of “same disease or condition” was not ambiguous merely because Congress did not provide an explicit definition in the statute.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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FDA Law Blog

FEBRUARY 2, 2023

As FDA notes in its budget request, “FDA cannot develop and implement alternative methods alone, so through this initiative FDA will expand qualification processes, provide clear guidelines to external stakeholders developing alternative methods, and fill information gaps with applied research to advance new policy and guidance development.”

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GeriPal

OCTOBER 13, 2022

And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. And that led to many specialists doing work and advancing their fields within their professional societies, providing guidance and so on for older adults.

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FDA Law Blog

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. We have also noticed a renewed emphasis on requirements related to remedial compliance programs in these civil settlements, often including a Memorandum of Agreement (MOA) with DEA and in some cases requiring a third-party auditor. Background.

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FDA Law Blog

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. We have also noticed a renewed emphasis on requirements related to remedial compliance programs in these civil settlements, often including a Memorandum of Agreement (MOA) with DEA and in some cases requiring a third-party auditor. Background.

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FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). 351, 355-56 (1985). l 56(c)(4) and 37 C.F.R.

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GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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GeriPal

MARCH 2, 2023

This long and sordid history of gabapentin and pregabalin is beautifully described in Seth Landefeld and Mike Steinman 2009 NEJM editorial. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Cochrane Database of Systematic Reviews Review. Annals of IM.

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GeriPal

NOVEMBER 7, 2024

And I think the question for our field is, is that because the estimates that we have of GFR based on creatinine provide misrepresentation or an inaccurate representation of someone’s kidney function. Do target trials differ from randomized trials and “ordinary” observational studies, or do they differ?!? Eric is skeptical.

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GeriPal

MARCH 7, 2024

We are delighted to welcome Jane Euler, who is lead doula and co-founder of Present for You, which is a benefit LLC company that provides doula support at the end-of-life. Who do we have on with us today? Alex: End-of-life doulas. Jane, welcome to the GeriPal podcast. Jane: Thank you for having me. John: I do. It was on his last album.

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GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner.

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FDA Law Blog

JANUARY 22, 2025

And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft Good Reprint Practices guidance since 2009. In any event, you whippersnappers should look up the album No Jacket Required its a classic.) This final guidance (16 years in the making!)

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GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. I went into emergency medicine to act. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC. They got feedback. So did it matter?

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FDA Law Blog

AUGUST 29, 2024

3582 —well before the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) established the biosimilar biological product licensure pathway, and years before the U.S. Like previous iterations of the bill, it would amend the FTC Act to add new Section 27, which provides, in part, that: (A) In general.—Subject Actavis, Inc. ,

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GeriPal

MARCH 10, 2022

The Lived Experience of Providing Feeding Assistance to a Family Member with Dementia. Well, I’m a geriatric nurse practitioner and I provided care to over 800 nursing home residents in 11 different nursing homes. I was really struck by the difference in care provided to people with advanced dementia. Rehabbed to Death.

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PEMBlog

APRIL 4, 2025

And so I do encourage you to be familiar with some of the information provided by the CDC as long as it’s still online. Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. So how common is it for children to be unvaccinated in the United States?

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Physician's Weekly

JUNE 27, 2025

In an email, Vianca Rodriguez Feliciano, a spokesperson for the Department of Health and Human Services, said the agency “is committed to supporting a strong, stable long-term care workforce” and “continues to work with states and providers to ensure quality care for older adults and individuals with disabilities.”

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