FDA Law Blog

FEBRUARY 4, 2024

That CMS teamed up with its sister agency to support FDA’s proposed rule is itself unusual. The joint press release largely repeats, and has CMS endorse, the arguments FDA has previously made in support of its proposed rule, which we rebut in the detailed comments we filed on behalf of a coalition of laboratories.

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PEMBlog

MAY 17, 2023

In: Textbook of Pediatric Emergency Medicine, 5th, Fleisher GR, Ludwig S, Henretig FM (Eds), Lippincott Williams & Wilkins, Philadelphia 2006. Why then do we persist with the “is it medical/organic or psych” question? It is also episode 1 in a 5 episode series focused on agitation in children and adolescents.

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PEMBlog

OCTOBER 26, 2023

2006 Oct;99(10):501-5. Background Meckel diverticulum is a congenital abnormality of the small intestine and is the most common cause of significant lower gastrointestinal bleeding in children. It arises from incomplete involution of the vitelline duct during embryonic development, typically occurring by the 7th week of gestation.

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FDA Law Blog

JANUARY 18, 2024

The EU prohibited it in 1999, almost immediately after FDA approved the testing methods at issue here, and Canada banned it in 2006. Last November, FDA published a notice of a proposal to withdraw approval of the three carbadox New Animal Drug Applications (“NADAs”) under 21 U.S.C. 360b(d)(1)(I). But did FDA pig out?

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FDA Law Blog

NOVEMBER 1, 2023

In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways). In support for this position, FDA states that hospitals that reprocess single-use devices have been viewed as manufacturers and points to its own webpage for support.

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FDA Law Blog

JUNE 21, 2022

35 U.S.C. § 271(a)(2); see also Teva Pharms. Though the Agency’s memorandum provides little interpretive justification for this new approach, it appears to be based entirely on a superficial change in administrative practice. Product Number: 001”) from the Orange Book and create[] a new entry and new product number (e.g., Product Number: 001”).

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FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code LZS.

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Permanente Medicine

JUNE 3, 2025

I joined SCPMG straight from residency in 2006. Don’t miss out on this compelling conversation — watch the chat on YouTube or listen to it on your podcast platform of choice. And don’t forget to subscribe so you don’t miss future Permanente Medicine programming. Guest Wadie L. Marcos, D.O. Marcos, tell us who you are and what you do.

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CDOCS

MARCH 15, 2021

important;" xml:lang="EN-US">We started our small, little company way back in the day in 2006. You see, we used to be cerecdoctors.com, focusing on just CEREC education, and the magazine was to be a print version that would be sent out quarterly, highlighting the trends with the CEREC system.

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The Health Policy Exchange

MARCH 14, 2013

Health Policy Fellowship Department of Family Medicine Georgetown University School of Medicine *Note: I was employed as a medical officer at AHRQ from October 2006 through December 2010. Although the agency survived, this experience eventually drove it out of the guideline-producing business for good. lined up to defend the agency.

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Annals of Family Medicine

NOVEMBER 20, 2024

A 2006 study conducted at Marie Curie Hospice Edinburgh found 29% of 164 patients in hospice did not have a documented preferred place of death, indicating room for improvement in documenting this important EOL wish. Unfortunately, EOL discussions may not always include conversations around preferred place of death.

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Today's Hospitalist

JUNE 7, 2025

” Phyllis Maguire has been Executive Editor of Today’s Hospitalist since 2006. Nor should they be. “I would not recommend starting a GLP-1 in the hospital.” “You want someone who can monitor patients’ side effects and have a longitudinal relationship with them.” “We really don’t yet know.”

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Permanente Medicine

APRIL 29, 2025

million men and women aged 50 to 75 examined the outcomes of a Kaiser Permanente Northern California initiative begun in 2006 to increase colorectal cancer screening rates. Findings from the study demonstrate how routine cancer screening with a test that can both prevent cancer and lead to earlier detection helps enhance quality of care.

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GeriPal

MARCH 2, 2023

2006 Transcript Eric: Welcome to the GeriPal Podcast. 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. One thing is clear, it is not because people are using it for FDA approved indications. Cochrane Database of Systematic Reviews Review. Annals of IM.

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FDA Law Blog

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). The MQSA was passed to ensure, among other things, that nationwide, patients have access to quality mammography services. Your breast tissue is not dense.

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GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. We also talk about the eligibility for the unit, what makes it run including the interdisciplinary team and the inmate peer workers, and the topic of compassionate release.

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FDA Law Blog

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. But like cockroaches, some pieces of legislation are resilient and never seem to die. 3) CIVIL PENALTY.

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FDA Law Blog

FEBRUARY 4, 2025

In 2006, David Ridley, Henry Grabowski, and Jeff Moe proposed a voucher in an article in Health Affairs as an incentive to develop therapies for neglected infectious and parasitic diseases that affect hundreds of millions of people in the developing world. Below, we discuss some of its downstream impacts on the PRV landscape.

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FDA Law Blog

DECEMBER 3, 2024

Such penalty shall accrue to the United States and may be recovered in a civil action brought by the Commission, in its own name by any of its attorneys designated by it for such purpose, in a district court of the United States against any party that violates this section. 3) CIVIL PENALTY. Jarkesy, 144 S. A lot has happened since then of course.

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GeriPal

JULY 6, 2023

Started as a direct case manager, worked in a variety of different places including the state legislature and I’ve been with the state office now since 2006. Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? Susan: It is my anthem. Eric: Wonderful, Susan.

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Physician's Weekly

JUNE 12, 2025

The two had access to the CDC database in 2004 and 2006. It’s unclear if he has regained access. In a statement, an HHS spokesperson said, “This scientific work will take a fresh look at all data including old data.” It added that “HHS will follow the science — wherever it leads.” But some public health leaders are concerned. “He

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GeriPal

MAY 1, 2025

Meredith wore a shirt that said Silence=death. Eric gave me the hook during my live cover of One, by U2, a song released in 1992 whose proceeds went entirely to AIDS research. I couldnt help it, forgive me dear listeners, I had to do a longer than usual cut at the start! But this song was actually a fundraiser for AIDS when it was released.

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GeriPal

DECEMBER 21, 2023

Summary Transcript Summary We’ve talked a lot about comprehensive dementia care on the GeriPal podcast but while the evidence is clear that these programs work, the uptake has been limited largely because there hasn’t been a strong financial case for it. It requires a fight. It’s been going on for many decades now. Malaz: I love it.

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FDA Law Blog

JUNE 9, 2021

As explained in CPG 440.100 and on FDA’s website , FDA adopted the “Unapproved Drug Initiative” (“UDI”) in 2006—later revised in 2011 —to remove unapproved drugs from the market using a risk-based approach both to ensure the safety and efficacy of all drug products on the market and the integrity of the drug approval process.

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Common Sense Family Doctor

MARCH 23, 2025

Despite this deliberately circumscribed mandate (I lost count of the number of times during my tenure as an AHRQ medical officer from 2006-2010 that I was told, "We don't make guidelines. Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency.

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