Medical Xpress

FEBRUARY 24, 2023

Indonesian children under 18 were 70 times more likely to be living with diabetes in January 2023 than they were in 2010, the Indonesian Pediatric Society revealed this month.

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StorytellERdoc

JULY 10, 2014

I originally wrote this piece in December, 2010. Recently, I learned that it has been "reborn" in the social media world with over 120k shares from just one resource (thank you, KevinMD). Please feel free to share your thoughts and experiences. To pain control issues. What followed was the briefest of conversations. For how long?"

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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. Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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My Green Doctor

MAY 3, 2025

A 2010 research study found that treating two patients per bottle instead of one would decrease plastic waste by approximately 12.69 Eye 24 , 361–363 (2010). Author: Ishani Majmudar Medical waste is rising tremendously each year, and its implications are not slight. tons in the United Kingdom each year. 3 “Each U.S. Sternberg, P.,

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Common Sense Family Doctor

DECEMBER 14, 2024

Surveillance, Epidemiology, and End-Results (SEER) prostate cancer database found that among men with intermediate-risk prostate cancer (based on pathology and a PSA level lower than 20 ng/mL), active surveillance or watchful waiting increased overall from 5% in 2010 to 12.3% Watchful waiting refers to clinical observation only.

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The Clinical Problem Solvers

JANUARY 18, 2021

2010 Oct;71(8):1390-8. Epub 2010 Aug 11. 1:05:57 Outtakes Takeaways Name Racism for What It Is If we don’t explicitly say the word racism, and identify its historical context, then we are complicit in its denial. This means that anti-racism must be embedded into practice, performance standards and institutional culture.

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Medical Xpress

APRIL 19, 2023

A new study by public health researchers presents stark evidence that the Central African Republic (CAR) is experiencing a severe health and humanitarian emergency, with what is likely the highest measured nationwide mortality rate in the world, a rate four times higher than a 2010 United Nations estimate.

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FDA Law Blog

AUGUST 12, 2024

In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency. The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. When the U.S. While Nissan et al.

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PEMBlog

OCTOBER 11, 2023

Pediatric genitourinary injuries in the United States from 2002 to 2010. The bladder is a hollow organ and therefore is relatively protected when empty, which makes rupture uncommon. However, in pediatric patients whose pelvic bones are not fully developed, the bladder is more prone to injury. 2013 Jan;189(1):288-93. doi: 10.1016/j.juro.2012.09.003.

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Myriad Genetics

MAY 20, 2025

Lavrakas served the American Association for Public Opinion Research (AAPOR) as its first Conference Operations chair in 1996-1997, as Program Chair in 1997-1998, and as Senior Counselor at Large in 2008-2010. In 2003, he was the co-winner of the AAPOR Innovator’s award for helping to establish the Standard’s Definitions Manual.

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CDOCS

JULY 22, 2019

& </p> <p>Here are some of my early cases starting in 2010. My point in this post is to show a progression of what you can do if you are vulnerable enough to put yourself out there and try. & I happen to have a really poor post-op photo of my very first anterior case. Now did I cut the crowns off and redo the case?

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The Clinical Problem Solvers

JUNE 12, 2022

A problem representation (PR, or Summary Statement) is an evolving, concise summary that highlights the defining features of a case , helping clinicians generate a focused differential diagnosis and identify the next steps in diagnosis and treatment. One more important point: the problem representation is dynamic.

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FDA Law Blog

JULY 13, 2022

This period is seemingly arbitrary given that biosimilars have only existed since 2010, and it’s entirely possible that the development of a biosimilar version of a reference product approved 16 years ago could take longer than a product that was approved 8 years ago. Koblitz & Kurt R.

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My Green Doctor

MAY 3, 2025

A 2010 research study found that treating two patients per bottle instead of one would decrease plastic waste by approximately 12.69 Eye 24 , 361–363 (2010). AP News At My Green Doctor, we believe environmental sustainability should be part of every healthcare conversation—and every clinic’s business plan. 3 “Each U.S. Sternberg, P.,

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Barton Associates

JUNE 19, 2025

Relying solely on permanent staff can lead to periods of over- or under-staffing, as patient volumes fluctuate due to various factors: Seasonal illnesses (e.g.,

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FDA Law Blog

SEPTEMBER 30, 2022

This is what these authors worked to do in 2010 and 2015 when we catalogued and characterized the application of appropriate flexibility in FDA approvals of orphan drugs, shedding light on these important issues (see coverage of here ). By Frank J. Sasinowski & James E.

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FDA Law Blog

AUGUST 12, 2021

Though Congress enacted the pathway for approval of interchangeable biosimilars in 2010 in an effort to incentivize competition to address the high prices of biologics, no sponsor had yet to crack the code to interchangeable approval until now. As FDA states in its Press Release, “Biosimilars marketed in the U.S.

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FDA Law Blog

APRIL 17, 2024

Drug Take Back Days have made appearances each spring and autumn since 2010. Events over the years have led to the removal of more than 17.9 million pounds of unwanted medication across the country. Additional information about DEA’s National Prescription Drug Take Back Day, including local disposal venues, can be found here.

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FDA Law Blog

JULY 11, 2023

As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.” As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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FDA Law Blog

JUNE 21, 2022

35 U.S.C. § 271(a)(2); see also Teva Pharms. Sebelius , 595 F.3d 3d 1303, 1318 (D.C. Though the Agency’s memorandum provides little interpretive justification for this new approach, it appears to be based entirely on a superficial change in administrative practice. Product Number: 001”).

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FDA Law Blog

OCTOBER 19, 2022

DEA’s Take Back Day in April collected more than 720,000 pounds of unneeded medication at 5,144 collection sites and has collected nearly 16 million pounds of medication since 2010. More information about DEA’s National Prescription Drug Take Back Day, including disposal locations, can be found here.

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CDOCS

APRIL 14, 2021

<br /> <br /> In 2010, I upgraded to the Bluecam and also added the necessary armamentarium to be able to produce e.max restorations in office.& & & First, you&rsquo;re getting a CEREC system for single unit posteriors.& & They, just like me, were engaged instantly by the technology.&

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GeriPal

DECEMBER 2, 2022

When was that, 2010? Eric: 2010. Summary Transcript Summary. What would it take to transform dementia care? Alex: We have a full house today. We’re delighted to welcome Judy Long, who’s a palliative care chaplain at UCSF and a caregiver. Judy, welcome to the GeriPal podcast. Judy: Thank you. It’s great to be here.

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

OCTOBER 19, 2023

DEA has held Drug Take Back Days each spring and autumn since 2010. DEA is not a band, but along with its law enforcement partners, the agency will host thousands of local drop-off locations nationwide for clearing out and proper disposal of expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 p.m.

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FDA Law Blog

OCTOBER 6, 2021

By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. Code Ann. § Becerra , No.

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FDA Law Blog

NOVEMBER 7, 2021

According to the court, HRSA consistently represented before December 2020 that its 1996 and 2010 guidance documents were non-binding and that the agency had limited authority to issue enforceable regulations regarding contract pharmacy arrangements. As discussed above, the judge found that the statute was silent on the issue.

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FDA Law Blog

NOVEMBER 1, 2023

In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways). In support for this position, FDA states that hospitals that reprocess single-use devices have been viewed as manufacturers and points to its own webpage for support.

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FDA Law Blog

MAY 30, 2024

In 2010, the Health Resources and Services Administration (HRSA) authorized covered entities to contract with an unlimited number of retail pharmacies to fill prescriptions for their patients. Initially, drug manufacturers were required to offer these discounts only to the in-house pharmacies of covered entities.

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FDA Law Blog

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

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FDA Law Blog

APRIL 4, 2022

He maintained an active practice until our 30th Anniversary on March 17, 2010, when he took senior counsel status. Jim is survived by Sophia, his wife of 57 years, his three sons and their wives, Evan and Nicola, Morgan and Mijiko, Michael and Kimberley, and 9 grandchildren. Some of these photos are proudly hung on the walls of our firm.

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FDA Law Blog

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs.

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FDA Law Blog

AUGUST 18, 2024

Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. There was no time limit for De Novos, which meant some requests languished for prolonged periods. For the first fifteen years after the De Novo program was established, it was basically a failure.

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FDA Law Blog

SEPTEMBER 29, 2021

Use of contract pharmacies ballooned after a guidance issued by HRSA in 2010 allowed covered entities to use multiple contract pharmacies to dispense drugs to covered entity patients. HRSA based its opinion on the statute and agency precedents over the last 25 years. see for example, this letter to Astra Zeneca).

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FDA Law Blog

FEBRUARY 27, 2024

2010) , however, the U.S. 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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FDA Law Blog

MARCH 30, 2022

FDA from January 2010 to June 2017 ” as evidence to support the premise above. Karst — It was some time ago that we posted on what we though was “the Good” in an avalanche of FDA-related legislation that we sorted into three categories: the Good, the Bad, and the Ugly. things too—come to those who wait! It’s regime change!

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The Health Policy Exchange

MARCH 14, 2013

From 2010 AHRQ Annual Conference presentation by Dr. Francis Chesley, Jr. Health Policy Fellowship Department of Family Medicine Georgetown University School of Medicine *Note: I was employed as a medical officer at AHRQ from October 2006 through December 2010. Supporters of health services research in the U.S.

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