Permanente Medicine

APRIL 16, 2025

Since 2009, TPMG has been affiliated with Maryland-based MAPMG, which comprises nearly 1,800 physicians in 60 specialties, providing care for 768,000+ Kaiser Permanente members in the region. Its more than 1,300 physicians span 54 specialties and provide care for more than 612,000 Kaiser Permanente members in the region.

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Medical Patient-Centered Community Hospital 52

FDA Law

JUNE 16, 2022

The most recent version of Endorsement Guides dates from 2009. By Riëtte van Laack — Last month, the FTC announced and posted a prepublication of its proposed changes to its guides concerning the use of endorsements in advertising (Endorsement Guides). The Endorsement Guides date back several decades.

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IT 52

FDA Law

APRIL 6, 2025

This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

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IT Manufacturing Provider Families 59

FDA Law

OCTOBER 3, 2022

Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.

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Consulting Healthcare Professional Government Specialization 105

FDA Law

MARCH 7, 2024

Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. In 2009 I served as Chair of NORD and through the hard work of countless colleagues we inaugurated the first Rare Disease Day. By Frank J. recognition of Rare Disease Day.

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Government Community Specialization Education 69

FDA Law

OCTOBER 9, 2022

In 2016, DEA denied two petitions — originally filed in 2011 and 2009 — after HHS concluded that marijuana continued to meet schedule I criteria by having a high potential for abuse, no accepted medical use in the United States, and lacking an acceptable level of safety for use even under medical supervision.

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Medical Individual IT 105

FDA Law

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. FDA originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it.

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FDA Law

FEBRUARY 16, 2022

In 2009, Catalyst’s drug Firdapse (amifampridine phosphate) received Orphan Drug Designation for Lambert-Eaton Myasthenic Syndrome (“LEMS”), and FDA subsequently approved Firdapse in November 2018 for the treatment of LEMS in adults with 7 years of Orphan Drug Exclusivity.

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FDA Law

AUGUST 2, 2022

Within the last month, the Cannabis Regulators of Color Coalition (“CRCC”) and handful of Democratic Senators have separately reached out to Biden Administration officials, including Attorney General Merrick Garland, requesting action to mitigate or eliminate federal prohibition on the use of cannabis. 21 U.S.C. § 812(b)(1). 26, 2022).

Medical 96

Medical Individual Provider Community 96

FDA Law

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). However, there’s a clear shift in FDA’s approach that is noticeable from the title of the Draft Guidance, alone.

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Clinic Clinical Practice Provider Utilities 64

PEMBlog

MAY 11, 2023

There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). 2009 May;16(5):388-93. Epub 2009 Apr 15. Acad Emerg Med.

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Patient-Centered IT Provider Patients 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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Clinic Education Clinical Practice Patient-Centered 52

CDOCS

APRIL 14, 2021

& When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & & First, you’re getting a CEREC system for single unit posteriors.&

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IT Patients Provider Appointment 52

FDA Law

OCTOBER 4, 2021

Importantly, the orphan drug designation, awarded in 2009, had been for LEMS generally—not LEMS in adults. In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute.

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IT Patients Provider Manufacturing 52

FDA Law

FEBRUARY 2, 2023

For more on FDORA’s other provisions, see HPM’s complete summary here ). Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans.

Clinic 64

Clinic IT Utilities Government 64

FDA Law

AUGUST 12, 2024

While FDA had acknowledged this approach, in its 2022 remand decision FDA said that such approach was an “improper application” of the regulation and that the Agency started differentiating the opening of the INAD file from submission of an NCIE in 2009. The “review phase” is the period between the initial submission and approval of the NADA.

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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. When I’m on service these days there is inevitably a moment when a resident says “Patient so-and-so is on X” – and I have absolutely no idea what X is.

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Complication Patient-Centered IT Patients 97

PEMBlog

JULY 17, 2023

11, 2009, pp. The original post was authored by Ashley Endres in 2018. this is an updated version for July 2023 Replace a G-tube Gastrostomy tube dislodgment and malfunction are top causes for G-tube related ED visits in pediatric patients so it is important to understand how to replace a G-tube. surgery or GI) before you mess with it.

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IT Families Family Complication 52

FDA Law

FEBRUARY 21, 2022

Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012. After regulatory authority for therapeutic biologics was transferred from CBER to CDER in 2003, Dr. Unger joined CDER as the Deputy Director of the Division of Cardiovascular and Renal Products.

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Patient-Centered Management Hospital Medical 40

FDA Law

MAY 3, 2021

Beginning about 2009, DEA “intensified its regulatory activities to help the registrant population better comply with the CSA and to identify those registrants who violated the CSA and implementing regulations.” Thus, non-compliance can be very costly, so it is more important than ever to dot every “i,” cross every “t.”.

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Management Manufacturing Specialization IT 52

FDA Law

MAY 3, 2021

Beginning about 2009, DEA “intensified its regulatory activities to help the registrant population better comply with the CSA and to identify those registrants who violated the CSA and implementing regulations.” Thus, non-compliance can be very costly, so it is more important than ever to dot every “i,” cross every “t.”.

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Management Manufacturing Specialization IT 40

FDA Law

FEBRUARY 27, 2024

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. § Absent a convincing showing, the Office after considering all of Applicant’s argument plans to issue only one PTE directed to ZYDELIG® (idelalisib). l 56(c)(4) and 37 C.F.R.

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Patients IT Provider Individual 59

Newnan Family Medicine Associates

JUNE 12, 2025

First identified in 2009, this drug-resistant fungus has since spread to over 30 countries, causing severe and often deadly infections. Candida auris is a fungal infection that poses an urgent threat to public health. Despite its rise in the US, people remain unaware of the dangers of Candida auris.

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IT 52

GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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Common Sense Family Doctor

MARCH 28, 2025

In West Virginia, where the last reported case of measles was in 2009, physician advocacy groups successfully petitioned the governor to veto a 2024 bill passed by the state legislature that would have allowed private and parochial schools to opt out of state immunization requirements.

Vaccination 52

Vaccination Family Physician Illness Families 52

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. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Cochrane Database of Systematic Reviews Review. Annals of IM.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

NOVEMBER 7, 2024

Do target trials differ from randomized trials and “ordinary” observational studies, or do they differ?!? Eric is skeptical. Bottom line: if faced with the decision to initiate dialysis, waiting is generally better. Let it be (hint hint). Again, we’re going to be talking about conservative management versus dialysis in older adults.

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Management Patient-Centered Patients IT 116

Permanente Medicine

JUNE 25, 2025

per 100,000 in 2009 to 23.5 By building an integrated, patient-centered colorectal cancer screening program, we doubled screening rates, cut deaths by 50%, and made major strides in closing racial disparities in outcomes. A third of U.S. in 2000 to 79.8%

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Screening Preventive Care Preventative Care Patient-Centered 52

Permanente Medicine

APRIL 29, 2025

Early screening helps erase racial health disparities The study showed a significant reduction of colorectal cancer deaths among Black patients, which decreased from 52 per 100,000 in 2009 to 23.5 Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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Screening Checkup Integrated Care Electronics 52

FDA Law

FEBRUARY 9, 2022

29, 2009)). Houck — The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure to identify and resolve red flags. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 62,316, 62,341 (Oct.

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PEMBlog

MAY 24, 2023

2009 Nov;27(4):655-67, ix. 2009 Jun;21(3):196-202. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children. Coburn VA, Mycyk MB. Physical and chemical restraints. Emerg Med Clin North Am.

Management 54

Management Patient-Centered Physicals Finance 54

GeriPal

OCTOBER 20, 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. The recent focus on nursing facilities and long term supportive services during the pandemic, along with key gaps. How to make your voice heard and get involved.

Complication 52

Complication Patient-Centered IT Patients 52

FDA Law

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. In any event, you whippersnappers should look up the album No Jacket Required its a classic.) This final guidance (16 years in the making!)

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Specialization Medical IT Clinic 59

GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. 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. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

MARCH 7, 2024

But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer. When I heard Bubbles Up, I was really struck by two things. How do you see the light? You were a what?

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FDA Law

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. Supreme Court declined to hold, in FTC v. Actavis, Inc. , 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful.

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Manufacturing Provider IT 59

FDA Law

FEBRUARY 4, 2025

In the eleven years from 2009 to the end of 2019, FDA awarded 11 tropical disease PRVs for the development of therapies for diseases such as malaria, tuberculosis, dengue, and river blindness. Below, we discuss some of its downstream impacts on the PRV landscape. An Increased Interest in the Tropical Disease PRV Program? See Table 1.

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