FDA Law Blog

AUGUST 2, 2022

Cole providing guidance to U.S. The CRCC also states that clarifying that DOJ will refrain from prosecuting cannabis stakeholders whose activities are legal under state law and do not implicate a federal enforcement priority would provide needed assurance for individuals and companies who have heavily invested in the cannabis industry.

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Medical Individual Provider Community 96

FDA Law Blog

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA replied that its definition of strength including concentration was clear even in 2009. mg) and the concentration (e.g., mg/mL) for liquid parenteral drug products.

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IT Provider Clinic Medical 59

FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Law Blog

APRIL 6, 2025

million product applications belonging to 320 applicantsincluding the respondentsconcluding that the manufacturers failed to provide sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. In short, FDA had provided largely noncommittal guidance.

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IT Manufacturing Provider Family 59

PEMBlog

MAY 11, 2023

There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). Neither HR nor NCFS differed, and perception of pain by provider, and need for additional lidocaine were similar. 2009 May;16(5):388-93. Epub 2009 Apr 15. 95% confidence interval = 1.01-3.93;

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Patient-Centered IT Provider Patients 52

FDA Law Blog

AUGUST 12, 2024

The Court pretty quickly determined that “FDA acted arbitrarily and capriciously when applying [the PTE statute] to BRAVECTO because the FDA did not provide fair notice or an adequate explanation of its shift in methodology.” FDA was required to provide fair notice that it would no longer use the INAD date to start the testing phase.

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Provider IT Consulting Medical 59

CDOCS

APRIL 14, 2021

& When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& </span></p> <p><span style="font-size:14px;">The 4-Y composition of the 3M Chairside Zirconia has provided excellent clinical results with a unique blend of esthetics and strength.&

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IT Patients Provider Appointment 52

FDA Law Blog

FEBRUARY 2, 2023

As FDA notes in its budget request, “FDA cannot develop and implement alternative methods alone, so through this initiative FDA will expand qualification processes, provide clear guidelines to external stakeholders developing alternative methods, and fill information gaps with applied research to advance new policy and guidance development.”

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Clinic IT Utilities Government 64

The Clinical Problem Solvers

DECEMBER 16, 2020

2009 May;139(1):47-57. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Embodiment: a conceptual glossary for epidemiology. J Epidemiol Community Health. 2005;59(5):350-355.

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. They are not authorized to inspect financial data, sales data other than shipment and transaction data, or pricing data unless the registrant provides written consent. Background. 21 U.S.C. § 21 U.S.C. §

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Management Manufacturing Specialization IT 52

FDA Law Blog

OCTOBER 4, 2021

Importantly, the orphan drug designation, awarded in 2009, had been for LEMS generally—not LEMS in adults. Reviewing the decision de novo , the Eleventh Circuit determined that the definition of “same disease or condition” was not ambiguous merely because Congress did not provide an explicit definition in the statute.

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IT Patients Provider Manufacturing 52

FDA Law Blog

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. They are not authorized to inspect financial data, sales data other than shipment and transaction data, or pricing data unless the registrant provides written consent. Background. 21 U.S.C. § 21 U.S.C. §

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Management Manufacturing Specialization IT 40

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. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm. 351, 355-56 (1985).

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Patients IT Provider Individual 59

GeriPal

OCTOBER 13, 2022

And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. And that led to many specialists doing work and advancing their fields within their professional societies, providing guidance and so on for older adults.

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Complication Patient-Centered IT Patients 97

GeriPal

NOVEMBER 7, 2024

And I think the question for our field is, is that because the estimates that we have of GFR based on creatinine provide misrepresentation or an inaccurate representation of someone’s kidney function. But you’re right, there has been a shift in policy to incentivize patients and providers to choose home therapies.

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Management Patient-Centered Patients IT 116

GeriPal

MARCH 2, 2023

This long and sordid history of gabapentin and pregabalin is beautifully described in Seth Landefeld and Mike Steinman 2009 NEJM editorial. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? Cochrane Database of Systematic Reviews Review. Annals of IM.

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Patient-Centered IT Healthcare Medical 96

FDA Law Blog

JANUARY 22, 2025

And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft Good Reprint Practices guidance since 2009. This final guidance (16 years in the making!) medical or scientific/technical representative or department).

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Specialization Medical IT Clinic 59

GeriPal

MARCH 24, 2023

She happened to focus on some specific for-profit hospice providers. They were all actually publicly traded or private equity owned for-profit hospice providers. And I didn’t read it as damning of all for-profit providers, but I think it needed to happen. It feels somewhat random in some ways. Eric: Lack of a caregiver.

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IT Provider Patients Family 114

GeriPal

MARCH 7, 2024

We are delighted to welcome Jane Euler, who is lead doula and co-founder of Present for You, which is a benefit LLC company that provides doula support at the end-of-life. We are doulas for those with serious illness and those at end-of-life, just a longitudinal relationship, nonmedical support to provide presence. Jane: Right.

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Provider Illness IT Healthcare 117

FDA Law Blog

AUGUST 29, 2024

3582 —well before the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) established the biosimilar biological product licensure pathway, and years before the U.S. 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 Actavis, Inc. ,

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Manufacturing Provider IT 59

GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. We weren’t randomizing providers or patients. This is not why I went into emergency medicine. I went into emergency medicine to act. So it was a cluster randomized trial.

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Patient-Centered IT Hospital Patients 77

GeriPal

MARCH 10, 2022

The Lived Experience of Providing Feeding Assistance to a Family Member with Dementia. Well, I’m a geriatric nurse practitioner and I provided care to over 800 nursing home residents in 11 different nursing homes. I was really struck by the difference in care provided to people with advanced dementia. Rehabbed to Death.

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PEMBlog

APRIL 4, 2025

And so I do encourage you to be familiar with some of the information provided by the CDC as long as it’s still online. In a study published in pediatric emergency care in 2009, Rutman and colleagues in a retrospective cohort of children less than five found that in comparison, occult pneumonia was identified more often.

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Vaccination Illness IT Clinic 68