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. Becerra, No.

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FDA Law Blog

APRIL 3, 2022

The new regulations seek “to eliminate this excessive reporting and more closely align the Board’s regulation with the federal regulation by providing increased clarity with respect to the quantities of controlled substance losses that must be reported.” 40,576, 40,578 (July 8, 2003).

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FDA Law Blog

MARCH 12, 2024

Failing to list the patents, as AstraZeneca points out, “may expose the reference drug sponsor to legal risks,” as “at least one generic applicant has argued that a failure to do so constitutes a violation of the antitrust laws by depriving the applicant of information that would have affected its decision whether to develop a generic product.”

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FDA Law Blog

JUNE 7, 2023

CMS will consider various factors, including the manufacturer’s costs of R&D and production, the drug’s comparative effectiveness, patents, and any therapeutic advances (see the full list of factors here ). With the IRA Negotiation Program, Congress jettisoned the voluntary agreement approach in all but name.

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FDA Law Blog

MAY 25, 2022

Section I provides data demonstrating the importance of the 180-day exclusivity incentive to generic competition. 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.

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FDA Law Blog

APRIL 23, 2021

The Court also looked at the structure of the FTC Act beyond §13(b) to §5(l) and §19 which provide for the imposition of limited monetary penalties and awards of monetary relief where the FTC has already engaged in administrative proceedings. 129 (2003). FDA’s response to our 2003 article, authored by Eric M. 169 (2003).

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FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. 2003) , and Biogen lnt’l v. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm.

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Physician's Practice

JUNE 20, 2025

Focus on providing optimum patient care and financial success will follow Rules are made for a reason and should be followed. Focus on providing optimum patient care, and the financial success will follow. Breaking them can lead to problems, fines, and even incarceration. Focus on making the product great, and the profits will follow.

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The Clinical Problem Solvers

APRIL 5, 2022

Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. By 2003, 37% were 50 and older. This episode was hosted by Sudarshan Krishnamurthy, Jazzmin Williams, and Alec Calac. Do you have a coordinated entry system (CES) in your community? Can you refer your patient there? 3.

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FDA Law Blog

AUGUST 29, 2024

Like previous iterations of the bill, it would amend the FTC Act to add new Section 27, which provides, in part, that: (A) In general.—Subject In particular, provisions have been added to expressly provide for the FTC to obtain forfeiture and civil penalties in an administrative proceeding initiated by the Commission. 1) FORFEITURE.—Each

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GeriPal

MAY 18, 2023

And then there was a version in 2003 which Mark participated in and he since passed. So the intention of the AGS Beers Criteria is to provide information primarily to clinicians, although to other audience as well, but medications that we consider to be potentially inappropriate in older adults. Mike: Thank you.

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FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired.

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GeriPal

MAY 12, 2022

And in 2003, I formed Pallium India with several colleagues with the national agenda, because still then the growth was mostly conveyed to Kerala and a couple of metropolitan cities. They run the Institute of Palliative Medicine, which is rather famous and excellent work going on. So, we wanted to have some activity spread around the country.

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GeriPal

MARCH 13, 2025

Eric 01:44 And we’re going to be talking about the roots of palliative care, and I think importantly, not just looking back, but what does that mean for our future as hospice and palliative care providers. But before we do, I think, Justin, you have a song request for Alex. Justin 01:59 Absolutely. It’s I Got a Name by Jim Croce.

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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). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

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GeriPal

APRIL 20, 2023

So we realized that we had a series of cross-sectional studies in San Francisco from the early 1990s to 2003. We looked at it and realized that in the early 1990s, 11% of folks were 50 and over, and by 2003, 37% were. But they would ask a bunch of questions.

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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).

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