FDA Law Blog

JUNE 12, 2023

PFI expressed some of its frustration with the current state of regulation of pet food by individual states in its comments on the Center for Veterinary Medicine (CVM) Virtual Public Meeting FDA and the AAFCO Animal Feed Ingredient Definition Process. PFI has noted that it is not feasible to develop and label products for an individual state.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. § 21 U.S.C. §

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Medical Xpress

JUNE 16, 2025

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. The content is provided for information purposes only.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. surgical robots, MRIs)?

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. She happened to focus on some specific for-profit hospice providers. JAMA Health Forum.

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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. By Philip Won & Lisa M.

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GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. We talk a lot about people being unhoused, which I think takes the blame away from the individual and kind of de.

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FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The preamble provides an example of reporting an incorrect baseline AMP, which reduces the unit rebate amount. Sheldon, v.

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GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? ” On that grand rounds, you differentiated structural factors from … I forget what the word was, individual- Margot: Individual risk factors. Why do we say “over 50” is “older” for homeless persons, why not 65? Margot: After 50.

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FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). (We We blogged on the December 5, 2023, letter from six Democratic governors to President Biden).

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Eric: Okay.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. She also mentioned Dr. Mark Kuczewski’s sanctuary doctrine toolkit that focuses more on the individual level.

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FDA Law Blog

AUGUST 3, 2021

CMS estimated that the rule would result in savings in individual out-of-pocket costs but such savings would be more than offset by increased premiums. The rule was estimated to cost the federal government around $196 billion over ten years. See bipartisan bill summary at 5.

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FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. Subtitle E is a slightly modified version of H.R.

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GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. What was life for you as a provider pre-pandemic? And so we’re able to provide access to those patients that may be home-bound or home limited or have a lot of struggles to get in. Stories trump data.

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Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. In the 1980s, the government refused to acknowledge HIV as gay men died young.

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FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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GeriPal

APRIL 17, 2025

Farah provides clear examples from the Biden administration, in which having the most diverse cabinet in history was critical to building bridges, empathy, and inspiring others to feel included. I think it was the 2023 World Series where Dusty Baker faced off as the manager of the Houston Astros against David Roberts. Well played.

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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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Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. At the height of the covid pandemic, he said, data produced by AHRQ and other government sources were outclassed by private sources.

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Physicians News Digest

APRIL 17, 2025

Harm to HIV, Vaccine Studies The NIH, with its nearly $48 billion annual budget, is the largest public funder of biomedical research in the world, awarding nearly 59,000 grants in the 2023 fiscal year. In November 2023, he told an anti-vaccine group, “I’m gonna say to NIH scientists, ‘God bless you all. Thank you for public service.

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