FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Marchetti , 96 F.4th

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FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).

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FDA Law Blog

SEPTEMBER 29, 2021

Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not. A 2018 report by the Government Accountability Office (“GAO”) found similar issues, as well as contract pharmacy noncompliance and poor federal oversight.

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FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). Indeed, back in 2014, we put together a review of more than 1,300 ANDA Suitability Petitions submitted to FDA since the enactment of the 1984 Hatch-Waxman statutory provision creating them. As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly.

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FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). Indeed, back in 2014, we put together a review of more than 1,300 ANDA Suitability Petitions submitted to FDA since the enactment of the 1984 Hatch-Waxman statutory provision creating them. As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly.

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Physician's Weekly

JUNE 16, 2025

from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues updated the 2014 policy statement on contraception for adolescents to provide pediatricians with evidence-informed and equity-informed practices in contraceptive care. ” Abstract/Full Text Copyright © 2025 HealthDay.

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GeriPal

MARCH 6, 2025

Naheed 15:56 2014. Eric 15:57 2014. I’m guessing, like here, especially in 2014, almost none of it was. Government is not the 51st state. Eric 15:54 What year did you start peach? How much of your training was focused on managing substance use disorder training and palliative care? Naheed 16:05 Yeah, you know.

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. We should be able to trust all the data that comes from our governing board. JAGS 2022 Trends in Antipsychotic and Mood Stabilizer Prescribing in Long-Term Care in the U.S.: Cochrane Database of Systematic Reviews Review.

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FDA Law Blog

SEPTEMBER 6, 2021

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. The catch is, as we have learned from the GSK v. Until recently, there hasn’t been a need for such a safe harbor, as Courts have not found inducement to infringe in this context, but the GSK v.

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GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. But Ruth, I was wondering too, and you invited us to ask each other questions, so my golly I’m going to do it.

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FDA Law Blog

MAY 26, 2025

149, 158 (2014). Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Anthony List v. Driehaus , 573 U.S. The AGs memo may well be relevant to establishing an impending and credible threat.

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