FDA Law Blog

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. As the co-founder of HP&M’s FDA Law Blog , Kurt often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.

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My Green Doctor

MAY 3, 2025

The Department of Energy’s Energy.gov – Enhanced Community Resilience : Clinics powered by renewable energy are better equipped to maintain operations during power outages, ensuring uninterrupted patient care during emergencies. The product manufacturers and vendors will need to be active partners as well.

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FDA Law Blog

MAY 2, 2022

They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. 21 U.S.C. § It is important to understand the lead up to Garland’s stance. Jefferson B. Sessions, Memorandum for All United States Attorneys, Jan.

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FDA Law Blog

JUNE 15, 2022

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Im­provement, and Modernization Act in 2003.

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GeriPal

JUNE 20, 2024

I mean, you could just argue that any kind of syndrome or condition that affects as many of half of older women in the community, as at least a third of older men in the community, really requires more creative approaches to delivering treatment. Alison 29:08 Yes.

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CDOCS

MARCH 15, 2021

Hardly a magazine, but more of a digital resource for our community. By going digital, we can bring information more rapidly, more targeted to what our audience wants, and be absolutely at the forefront of innovations and technology that our manufacturing partners bring.&

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Annals of Family Medicine

NOVEMBER 20, 2024

Setting and Population Studied: The ExPAND 2022-23 cohort supported 3 clinics in the Midwest (1 FQHC, 2 community hospital clinics). Study Design: This analysis reports change in practices as tracked through learning collaborative milestones and clinician/staff self-report. times those of pre-survey respondents (95% CI 1.10-3.87).

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison, a community organizer and trans theorist, and Dr. Psyche A. As an editor, movement media and narrative strategist, and storyteller, Harrison uses their extensive history as a community organizer—which began in 2014 during their first year at Morehouse College—to frame their political thought and cultural criticism.

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Community Manufacturing Patients Medical 52

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So it really helped form community between patients and helped build community with the palliative team that was involved. But also it brings community.

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FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however. Cook-Deegan et al.

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Manufacturing Clinic IT Vaccination 64

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

The new program has additional eligibility requirements, including that the physician must have practiced outside of a rural community for at least three years before returning to a rural area.

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Common Sense Family Doctor

FEBRUARY 15, 2025

On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns.

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GeriPal

MARCH 2, 2023

And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Eric: Although pregabalin, right, more misuse of pregabalin out in the community. So that’s kind of how it first came on my radar. Is that right?

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FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

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Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 24, 2022

I think it’s the first time in our community that we’ve had to wrestle with a disagreement, hence this podcast, or a different interpret of the evidence. First of all, this does feel primarily like a manufactured controversy. And I think we really need to be very careful about that. Other fields have had to do that.

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

DECEMBER 7, 2023

Leslie Wharton is a leader in the 26,000 member grassroots organization Elders Climate Action , which organizes older adults to create communities engaged in making a difference at local, state, and national levels. So yeah, we’re very focused on that. I mean, you are talking about a huge, huge network.

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FDA Law Blog

MAY 21, 2024

at 44,620-21 The Attorney General, based on OLC advice, concluded that marijuana could be rescheduled to schedule III, and that DEA would consider supplementing schedule III requirements with additional marijuana-specific controls such as manufacturing quotas and import and export authorizations to satisfy treaty obligations.

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Adventures of a Sick Doctor

JUNE 14, 2025

Not a single free #gifted experience in a luxury spa, not one complimentary cashmere scarf, no community fundraisers to pay for my Leonidas addiction. Hot dog manufacturers. I took a load of drugs, they worked (mostly) - super. The biggest mistake, probably, was the failure to cash in. Sir Henrys. Murphy & Sons. And pay up?

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Doctors for America

MAY 15, 2025

Americans are also increasingly unsafe as Kennedy has dismissed technical staff who inspect and ensure safety of facilities manufacturing drugs and goods. Our impact areas focus on access to affordable care, community health and prevention, and health justice and equity.

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Medical Student Medical Advice Vaccination Education 52

FDA Law Blog

DECEMBER 14, 2023

The governors concluded that it is time to act like “the greatest nation on earth” that the United States is by promoting safe products, taking enforcement action against dangerous products and entities that violate state law and focusing on the real problems the states face as a community “with opioid use at the top of the list.”

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Medical Manufacturing IT Education 59

Tiny Physician

OCTOBER 17, 2021

Later, due to mass outrage from the scientific community, the label of ‘drug for treatment’ was changed to ‘immunity booster’ (5). It is worth noting that Covaxin, our indigenously developed vaccine manufactured by Bharat Biotech, is on the verge of getting approval in the pediatric age group as well (6).

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FDA Law Blog

MAY 14, 2021

Even the African American community is split on the issue of a menthol ban. Others, including prominent Black leaders like Al Sharpton and civil rights organizations like the ACLU have strongly opposed such a ban for its prospect of criminalization a product popular in the African American community.

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FDA Law Blog

MAY 14, 2021

Even the African American community is split on the issue of a menthol ban. Others, including prominent Black leaders like Al Sharpton and civil rights organizations like the ACLU have strongly opposed such a ban for its prospect of criminalization a product popular in the African American community.

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FDA Law Blog

JUNE 27, 2022

If and when implemented, the amendments will likely force Medicare Part D plans and their PBMs to pass drug manufacturer rebates through to pharmacies to reduce out-of-pocket expenses of Part D enrollees, which would be a dramatic change from current practice.

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GeriPal

OCTOBER 31, 2024

And because MRNA vaccine someone nimbly manufacture, they can say hey, let’s just make a vaccine based on what’s currently circulating. And I was like, I don’t see much in the community right now. Now nursing homes, not really truly like community based outpatient, not really inpatient. Eric 38:41 Okay.

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