FDA Law Blog

AUGUST 2, 2022

As a reminder, cannabis remains a schedule I substance under the federal Controlled Substances Act (“CSA”), which by definition means it does not have an accepted medical use in treatment in the United States and thus cannot be legally sold or marketed for any purpose. 21 U.S.C. § 812(b)(1). 26, 2022). CRCC Letter, 3.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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PEMBlog

MAY 11, 2023

And what about the J-Tip, a device that uses pressurized gas to send medication into the subcutaneous portion of the skin – deeper than topical anesthetics? There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). 2009 May;16(5):388-93.

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FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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GeriPal

OCTOBER 13, 2022

Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. That includes many medical specialists, surgical specialists, many specialists and many other disciplines who are on our older adults team. Eric: Welcome to the GeriPal podcast.

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FDA Law Blog

FEBRUARY 21, 2022

From 1997 to 2003, Dr. Unger served as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (“CBER”). Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012.

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FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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FDA Law Blog

MAY 3, 2021

DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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FDA Law Blog

FEBRUARY 27, 2024

leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § Absent a convincing showing, the Office after considering all of Applicant’s argument plans to issue only one PTE directed to ZYDELIG® (idelalisib). l 56(c)(4) and 37 C.F.R.

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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

MARCH 24, 2023

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. 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. I’m excited.

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GeriPal

NOVEMBER 7, 2024

And the main topic of today is a paper in Annals of Internal Medicine , Maria first author, that addressed the tradeoffs between initiating dialysis vs continued medical/supportive management. Susan 01:36 To reflect continuing medical management versus starting dialysis, which is what Maria’s wonderful paper goes through.

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Permanente Medicine

APRIL 29, 2025

Early screening helps erase racial health disparities The study showed a significant reduction of colorectal cancer deaths among Black patients, which decreased from 52 per 100,000 in 2009 to 23.5 Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

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Permanente Medicine

JUNE 25, 2025

per 100,000 in 2009 to 23.5 Corley, MD, PhD, is chief research officer at The Permanente Medical Group and a research scientist at the Kaiser Permanente Northern California Division of Research. A third of U.S. in 2000 to 79.8% But at its core, this program is about communicating with patients and understanding their needs.

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FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 29, 2009)). Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 62,316, 62,341 (Oct.

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PEMBlog

MAY 24, 2023

For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Berzlanovich AM, Schöpfer J, Keil W. 2009 Nov;27(4):655-67, ix. 2009 Jun;21(3):196-202.

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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. medical or scientific/technical representative or department). medical or scientific/technical representative or department).

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GeriPal

OCTOBER 20, 2022

Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. That includes many medical specialists, surgical specialists, many specialists and many other disciplines who are on our older adults team. Eric: Welcome to the GeriPal podcast.

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Complication Patient-Centered IT Patients 52

GeriPal

MARCH 7, 2024

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. But before we jump into that topic, John, do you have the song request for Alex? John: I do.

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GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. 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. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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FDA Law Blog

FEBRUARY 4, 2025

As our readers may already know, FDA maintained three PRV programs to incentivize the development of therapies for underfunded diseases: the RPD PRV program, which sunset last month, the Medical Countermeasures (MCM) PRV Program, which sunset in October 2023, and the Tropical Disease PRV Program. See Table 1.

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GeriPal

MARCH 10, 2022

Many years ago for the first study; I believe it was in 2009, 2010; I met with Susan Mitchell at the Institute for Aging Research, and told her that I wanted to study the use of feeding tubes for people with advanced dementia. Welcome to the GeriPal Podcast, Caroline. Caroline: Thanks, Alex. I know it’s a mouthful. Thanks, Alex.

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PEMBlog

APRIL 4, 2025

So serious bacterial infection defined as any bacterial infection requiring medical intervention, but it may not invade sterile sites. Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. Unfortunately. It’s getting more common. Interesting.

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