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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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 ). In its complaint, Merck characterizes the Negotiation Program as coercive and draconian.

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Manufacturing Government IT Provider 45

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. In particular, Mr. Schultz and Ms.

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Manufacturing IT Patients Provider 40

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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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 financial success will follow Rules are made for a reason and should be followed. I have successfully found 10,000 ways that will not work."

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Management Patient-Centered Appointment Patients 52

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. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). 351, 355-56 (1985).

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Patients IT Provider Individual 59

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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Medical IT Patients Clinic 97

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. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. Do you have a coordinated entry system (CES) in your community?

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Community Patient-Centered Emergency Room Medical 52

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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Manufacturing Provider IT 59

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. If you read just one, read Palliative Medicine – Just Another Specialty ? by Kearney. I promise its short.

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IT Patient-Centered Families Family 105

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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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.

IT 52

IT Provider ER Insurance 52

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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Mental Health IT Community Individual 124

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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Medical Healthcare Professional Community IT 59

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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