FDA Law Blog

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

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FDA Law Blog

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. Is it based on the issue date of the original patent or the reissued patent?

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FDA Law Blog

NOVEMBER 29, 2021

This is especially important given that the SUPPORT Act of 2018 (section 2003) requires EPCS (with few exceptions) for those prescriptions covered under Medicare Part D beginning in January 2021. By Karla L. The proposed rule also just makes sense.

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FDA Law Blog

FEBRUARY 21, 2022

From 1997 to 2003, Dr. Unger served as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (“CBER”). Unger led a translational research program on promotion of angiogenesis. Unger joined CDER as the Deputy Director of the Division of Cardiovascular and Renal Products.

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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. citing 967 F.

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FDA Law Blog

APRIL 3, 2022

40,576, 40,578 (July 8, 2003). The Board is not joking now, for several reasons, including reducing the estimated number of an estimated 10,000 loss reports per year to 6,667 per year, and more closely aligning with federal requirements, has fine-tuned its loss reporting requirements.

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FDA Law Blog

JULY 26, 2022

Finally, the Patent Listing section of the Orange Book addresses some of the major issues FDA wrestled with in adopting the 2016 rules implementing the Medicare Modernization Act of 2003. The Guidance is a Frequently Asked Questions guidance that digs a little deeper into the Orange Book than it has in the past.

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FDA Law Blog

JUNE 7, 2023

N/A November 1 End of Negotiation Period Failure to agree to MFP may result in daily excise tax of up to 95% of US sales revenue* November 30 CMS publishes MFP Refusal to sell at/below MFP can result in CMPs of 10x the difference between the actual price and the MFP *unless manufacturer withdraws all its drugs from Medicare and Medicaid.

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FDA Law Blog

MAY 25, 2022

That effort, which has most recently emerged in the forms of the “ Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 ” ( H.R. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S. In particular, Mr. Schultz and Ms. That’s pretty powerful and compelling stuff!

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FDA Law Blog

APRIL 23, 2021

129 (2003). FDA’s response to our 2003 article, authored by Eric M. 169 (2003). Background on the case can be found in earlier posts here , here , here , and here. We conclude that it does not. It did that by focusing on the text of the statute. Fleder, Can FDA Seek Restitution or Disgorgement ? , 58 Food and Drug L.J.

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FDA Law Blog

MARCH 12, 2024

In their responses, each company emphasized that none of the patents listed were “sham patents” and that FTC never challenged the legitimacy of the patents. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book. And FDA still hasn’t said a thing!

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Physician's Practice

JUNE 20, 2025

Those who pave new roads and create new paths find the connections between what others have done and what works in their practices. Dr. Christian Chaussy, a urologist in Munich, Germany, noted pitting on the surface of an aircraft as it approached the sound barrier—a unique occurrence caused by the shock wave created in front of a drop of moisture.

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FDA Law Blog

FEBRUARY 27, 2024

2003) , and Biogen lnt’l v. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § The PTO’s not-even-specious-argument, citing what certainly appears to us to be absolutely irrelevant case law, such as Novartis AG v. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed.

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Georgetown Pediatrics & Family Medicine

MARCH 16, 2022

Patricia Goldman-Rakic (1937-2003) Neuroscientist Patricia Goldman-Rakic is recognised for her studies of the brain, particularly, the frontal lobes and how it relates to memory. Metrodora (c. 200-400 AD) Metrodora, a Greek female physician, wrote On the Diseases and Cures of Women, the oldest medical text known to be written by a woman.

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GeriPal

MAY 18, 2023

And then there was a version in 2003 which Mark participated in and he since passed. We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. Alex: We’re having Beers. laughter] Eric: Who do we have with us today? Alex: That’s what it was named after, right? We’ll learn about that.

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The Clinical Problem Solvers

APRIL 5, 2022

By 2003, 37% were 50 and older. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. If we do not know the housing status of our patients, then we do not know one of the most fundamental things that is going to affect their health and wellbeing. 2.

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GeriPal

MAY 12, 2022

Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. Community-based palliative care networks . Raj’s reflections on the state of palliative care in the US. Transcript.

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GeriPal

MARCH 13, 2025

I have felt as I’ve come through this field over the last, I guess 2003 is when I realized I wanted to be a palliative care doctor. If you read just one, read Palliative Medicine – Just Another Specialty ? by Kearney. I promise its short. But before we do, I think, Justin, you have a song request for Alex. Justin 01:59 Absolutely.

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FDA Law Blog

AUGUST 29, 2024

But like cockroaches, some pieces of legislation are resilient and never seem to die. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S. And like its predecessor bills, S. 142 includes narrow exceptions: (B) Exception.—Subparagraph

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FDA Law Blog

SEPTEMBER 6, 2021

Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired. Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs.

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Physician's Weekly

JUNE 12, 2025

The final findings were published in 2003. 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 More information The U.S.

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GeriPal

APRIL 20, 2023

How has the history of redlining and the federal tax subsidy of wealthy (mostly white) people in the form of a mortgage interest deduction contributed to racial inequalities in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What should we call it – homeless or unhoused? Eric: I love this.

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FDA Law Blog

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975. In other words, no rescheduling. Letter to President Joseph Biden, et al. from Senator Elizabeth Warren, et al. July 6, 2022).

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Tiny Physician

OCTOBER 17, 2021

al had published a case series way back in 2003 on Arsenic toxicity after consuming homeopathic medicines in which Arsenic was added therapeutically (8). Contrary to our beliefs, the second wave came and exposed all the weaknesses of our health system. It will be the last element to be included in a drug that is given to the masses.

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PEMBlog

FEBRUARY 22, 2024

Pediatrics 2003 July; 112(1):191-2. Newborn infants need intramuscular injections of Vitamin K in order to produce critical clotting factors. If they don’t get it they can have potentially life threatening bleeding. This is a podcast episode that reviews Vitamin K Deficient Bleeding AKA Hemorrhagic disease of the newborn.

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FDA Law Blog

JULY 12, 2021

The Order calls on FDA “to reduce the cost of covered products to the American consumer without imposing additional risk to public health and safety, [by working] with States and Indian Tribes that propose to develop section 804 Importation Programs.” The Executive Order places the Biden Administration firmly behind drug importation.

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Common Sense Family Doctor

JUNE 20, 2025

The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), which since 2003 had been making evidence-based recommendations about a list of conditions for which every newborn should be screened , was disbanded by HHS in April for no particular reason. Even worse, the study’s existing data are at risk.

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FDA Law Blog

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c). See 21 C.F.R.

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