FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. By Larry K. Houck Last month the U.S. Attorneys Office, Northern District of Illinois, April 21, 2025. 81, 86, 251. 81, 89, 251.

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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

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. Enforcement for these regulations also occurs both by federal and state officials.”

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FDA Law Blog

FEBRUARY 27, 2023

In an erratum filed to the deposition of an official previously self-identified as the Chief FOIA Officer, the government stated that the individual was in fact, not the Chief FOIA Officer for DEA but Chief of the FOIA/PA Unit at DEA. Aims Institute, PLLC, v. Merrick Garland, et. al , Case No. 4:2022-cv-02396 S.D.

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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.” It finalized a draft guidance published in 2022.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. By Larry K. 823(g)(1).

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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. But the NTU team discovered that it is far more complex.

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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. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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FDA Law Blog

APRIL 8, 2024

What about government factors that cause drug shortages? What the White Paper does not adequately address is whether there are any government-controlled factors that also cause drug shortages. In Section I.A, surgical masks, gloves) versus medical devices that represent large capital expenditures (e.g., surgical robots, MRIs)?

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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. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes it rewarding? those experiencing homelessness).

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FDA Law Blog

OCTOBER 17, 2023

In addition, criterion one can also apply to technologies and device features aimed at improving accessibility, defined as “an individual or group’s capacity to benefit from a medical device or procedure.” By Philip Won & Lisa M. Other Updates With respect to the first part of the first criterion (i.e., Emphasis added.)

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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. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Sheldon, v.

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GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? To what extent is the rise of tech in San Francisco to blame for our local rise in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What are the highest yield interventions and policy changes?

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FDA Law Blog

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. Letter to U.S. In other words, no rescheduling.

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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

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. By Faraz Siddiqui — On Monday August 2, 2021, the Senate took up for review H.R.

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The Clinical Problem Solvers

MAY 2, 2023

Gillette” Gillette-Pierce May 2, 2023 Summary: This episode highlights the psychosocial and cultural considerations for providing healthcare to immigrant and refugee populations. A lot of compounding trauma occurs at the border that has potential downstream mental health implications for individuals and their families.

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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. The Part D rebates would be paid each year instead of quarterly, beginning with rebates for 2023. Subtitle E is a slightly modified version of H.R. 3, the Elijah E.

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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. Start with a story as Carly did in her Op Ed. Stories trump data. Write to your congressperson. Before we do, I think, Joe, you have a song request for Alex. Joe: I do. Eric: Wait, which version? But not Space Oddity.

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Physician's Weekly

JUNE 25, 2025

In the 1980s, the government refused to acknowledge HIV as gay men died young. — Cedric Sturdevant woke up with “a bit of depression” but made it to church, as he does every Sunday. In a few days, he would drive from Mississippi to Washington, D.C., About 40% of adults with HIV rely on it for their lifesaving treatments.

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FDA Law Blog

NOVEMBER 18, 2024

Referencing an interview with Kennedy from 2023, the Post says that his views on health “were a head-scratching spaghetti of what we can only call warped conspiracy theories, and not just on vaccines.” The first point he made pertained to reforming the Prescription Drug User Fee Act (PDUFA). Washington Post, 10 RFK Jr.

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FDA Law Blog

MAY 26, 2025

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. First, it direct[s] all U.S.

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GeriPal

APRIL 17, 2025

What a Wonderful World could be sung in irony at this moment. I hope we all take it literally, with the hope this podcast ends with. Alex Smith ** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here. Transcript Eric 00:00 Welcome to the GeriPal Podcast. It is a terrific book. Alex 02:07 Yeah, I love it.

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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

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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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. A KFF Health News analysis underscores that the terminations are sparing no part of the country, politically or geographically.

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