FDA Law Blog

DECEMBER 13, 2023

Dr. Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

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FDA Law Blog

JUNE 29, 2022

Livornese — Last week, FDA issued a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation” (the Draft Guidance ), authored by CDER, CBER, and the Oncology Center of Excellence (it is interesting, though not surprising, to see the OCE as an author on this document, given the popularity of the program in oncology).

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PEMBlog

OCTOBER 2, 2024

2013-0421 Tighe M, Afzal NA, Bevan A, et al. I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Topics covered include: The pathophysiology of GER and GERD in the pediatric population. Understanding dyspepsia and its clinical presentation. 2018;66(3):516-554.

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GeriPal

JUNE 19, 2025

Noelle Marie 01:24 I think it really speaks a lot to my own personal journey and I’m pretty sure a lot of trans and gender diverse individuals also resonate with and it really speaks about our transition, celebrating our authentic selves, how society views us and how we view ourselves when we stand in front of a mirror.

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The Clinical Problem Solvers

MARCH 4, 2024

She discovered narrative medicine, and to her, it was about finding and retelling individual and structural stories in antiracist ways. Listening to individual stories within the context of their structural stories is important. Sayantani became a physician since she thought it was a concrete tool for social justice.

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GeriPal

SEPTEMBER 1, 2022

Social workers augment a team’s ability to provide whole-person care, often aiding to identify and meaningfully address the wide variety of challenges and unmet needs faced by individuals and families facing serious illness. Barbara: Oh, I think it was 2013. by: Anne Kelly, LCSW, APHSW-C. Transcript. This is Eric Widera. Is that right?

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ABIM

JUNE 11, 2025

Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.” The group discussed some of Dr. McDonald’s updates in greater detail.

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ABIM

JUNE 24, 2025

Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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The Medical Futurist

JUNE 17, 2025

Back in 2013, Russian scientists discovered a well-preserved woolly mammoth carcass trapped in the permafrost of northern Siberia for some 42,000 years. There are now nearly 300 cryogenically frozen individuals in the US, another 50 in Russia , and a few thousand prospective candidates signed up. Traveling in cryosleep to Mars?

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FDA Law Blog

OCTOBER 24, 2024

When it became possible to isolate the sequence of an individual gene from the genome, the Patent Office began issuing patents for them as compositions of matter. Courts have interpreted the statutory categories to exclude, inter alia , natural phenomena, including products of nature. animal, viral, bacterial) DNA and RNA sequences.

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FDA Law Blog

APRIL 8, 2024

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. However, a cursory review of the current FDA Drug Shortages list shows that of the 115 drugs “currently in shortage,” 76 are injections.

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GeriPal

MARCH 3, 2022

Alex: And we’re delighted to welcome you to the GeriPal Podcast, Julien Cobert, who is an intensivist and aging researcher GeriPal Podcast, Julien. Julien: Thanks Alex, thanks Eric. It’s great to be here. Eric: So we’re going to be talking about aging in the ICU. Chris Cornell is one of my favorite musicians. Alex: (Singing).

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FDA Law Blog

MAY 14, 2021

The announcement followed a Center of Tobacco Products (CTP) response to a citizen petition originally submitted in 2013 by anti-tobacco and public health groups (including prominent African American groups like the African American Tobacco Control Leadership Council) on prohibiting menthol cigarettes. 44,484 (July 24, 2013) (Menthol ANPRM).

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FDA Law Blog

MAY 14, 2021

The announcement followed a Center of Tobacco Products (CTP) response to a citizen petition originally submitted in 2013 by anti-tobacco and public health groups (including prominent African American groups like the African American Tobacco Control Leadership Council) on prohibiting menthol cigarettes. 44,484 (July 24, 2013) (Menthol ANPRM).

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Physician's Weekly

JUNE 11, 2025

The report found that the number of potential caregivers for an individual 80 or older will decrease significantly by 2050. Since 2013, Wisconsin has also had a unique network for dementia care, with state-funded dementia care specialists for each county and federally recognized tribe in Wisconsin. I get to meet them.

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The Clinical Problem Solvers

MAY 2, 2023

A lot of compounding trauma occurs at the border that has potential downstream mental health implications for individuals and their families. Identify the role of trauma-informed, culturally-responsive care for refugee, asylee, and immigrant populations and how it can be operationalized in clinical practice.

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GeriPal

JUNE 2, 2022

So take a listen and if you want a deeper dive into some of the references we discuss on the podcast, here is a list: Medscape article on how “ COVID-19 Vaccines Work Better and for Longer Than Expected Across Populations, Including Immunocompromised Individuals”. Stat news article about variants/COVID becoming more predictable. Alex: Great.

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GeriPal

JULY 16, 2024

On the one hand, they have concerns about cognitive fitness of candidates for office. On the other hand, they worry about ageism. There’s something happening here, and what it is ain’t exactly clear. We need clear eyed thinking about this issue. We do not endorse or disclose our personal attitudes toward any particular candidate. Ken 02:33 Bravo.

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Physicians News Digest

APRIL 3, 2025

But neither Kennedy nor President Donald Trump have explained why individual agencies such as AHRQ were targeted for cuts or indicated whether any of their work would continue. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals.

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