Physician's Weekly

JUNE 21, 2025

The study published in the June 2025 issue of the European Journal of Pain used data from the Finnish nationwide register-based study on Parkinson’s disease (FINPARK) to examine opioid use incidence from 5 years before to 5 years after a Parkinson’s disease (PD) diagnosis, comparing it with a matched control cohort. Pain was recognized as (..)

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Physician's Weekly

JUNE 26, 2025

The emergency room has become a pressure cooker, and healthcare professionals are paying the price. The severity of this problem has even made its way into pop culture. The Warner Bros. Created in consultation with emergency medicine professionals, the show aims to raise awareness and provide validation to frontline healthcare workers everywhere.

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The Clinical Problem Solvers

MAY 20, 2020

He received his undergraduate degree from the University of Pittsburgh, medical degree from Loyola University of Chicago, and completed his combined internal medicine/pediatrics residency at the Medical University of South Carolina in 2014. Roughly 10-12% of cases may present without rash (i.e.,

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Annals of Family Medicine

NOVEMBER 20, 2024

A semi-structured interview guide based on Daouk-Öyry’s (2014) joint model of nurse absenteeism and turnover was used. N=35 nurses were interviewed; n=6 primary care, n=7 emergency care and n=22 from other areas. Instrument. Outome Measures. Conclusions. Nurses leaving the primary and emergency care are experienced.

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FDA Law Blog

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

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PEMBlog

OCTOBER 11, 2023

2014 Aug;192(2):327-35. Epub 2014 May 20. 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. Clinical signs of bladder injury are nonspecific. doi: 10.1016/j.juro.2014.05.004.

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Annals of Family Medicine

NOVEMBER 20, 2024

SAFE used a stratified, two-stage, clustered design to obtain a nationally representative sample of mothers of infants; mothers were enrolled from 32 US birth hospitals, January 2011-March 2014. Context: Breastfeeding (BF) has many benefits for infant health. BF initiation and duration vary by parental characteristics (e.g.,

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Adventures of a Sick Doctor

JULY 4, 2024

Still though, he usually perks up when I come in, because he gets to show me my scans from November 2014 and compare them with now and we both applaud the wondrousness of the miracle that is my recovery. I am catching up on various emails and tasks that I have been ignoring for the past few weeks. Nothing has been written in it since then.

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Myriad Genetics

MAY 20, 2025

He was elected to serve AAPOR as its Vice President, President, and Past President from 2011-2014. He was elected to serve AAPOR as its Vice President, President, and Past President from 2011-2014. 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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FDA Law Blog

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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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

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

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Adventures of a Sick Doctor

NOVEMBER 7, 2020

The reason for my restricted movements was my Portacath, the small firm hockey-puck device which was implanted in the right side of my chest wall in December 2014. For six years I haven’t been able to sleep on my right side. I didn’t think it mattered that much. It waited, and waited, and waited. So they ask “When was your last period?”,

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PEMBlog

OCTOBER 31, 2024

2018 Nov 22;379(21):2002-2014. There were also no differences in the duration of diarrhea or vomiting, day-care absenteeism, or household transmission of symptoms. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. N Engl J Med. doi: 10.1056/NEJMoa1802598.

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AMMD

FEBRUARY 14, 2025

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. Additionally, it’s classified as stage 0, so it’s not nearly as scary as conventional medicine leads us to believe. In fact, I had a similar situation happen to me not too long ago. In 2024, I had another scare.

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The Clinical Problem Solvers

JANUARY 18, 2021

Published June 10, 2014. 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. Racism denial is deeply ingrained in our society and it needs to be called out and recognized as a system in order to be addressed.

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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

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

MARCH 18, 2025

In the generic filers view, the regulatory review period should have started in January 2014 when the patent was reissued rather than in April 2004, when the IND was opened, because the reissued patent did not exist in April 2004. Is it based on the issue date of the original patent or the reissued patent? The plain text of 35 U.S.C.

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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.

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FDA Law Blog

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. While Nissan et al. Thus, the Agency concluded, the June 2011 date should stand.

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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.

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FDA Law Blog

JUNE 29, 2022

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”

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FDA Law Blog

SEPTEMBER 13, 2022

The final guidance with the same title (Guidance), which we blogged about here at the time of release in 2014, provided additional clarity, but we find that, even with years of experience, it is still a challenge in many cases to decide how best to bring a second device into a substantial equivalence discussion.

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FDA Law Blog

JUNE 30, 2022

The federal track and trace process started in early 2014, and industry is accustomed to passing “T3” as required by the DSCSA, as well as relieved that overly restrictive state drug pedigree laws are indeed preempted. Gilbert — Oh what a feeling, we’ll be dancing on the ceiling as they say. 6,708 (Feb.

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FDA Law Blog

OCTOBER 14, 2024

2014); U.S. The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. 3d 1302 (11th Cir.

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BMJ

JULY 17, 2020

2014 (28 August). For example, individuals, including community health workers, potential stigmatizers, and even the stigmatized, need to cultivate a sense of caring and sympathy for those infected and for other stigmatized groups in the community. National involvement is also needed to facilitate these efforts. doi:10.3389/fcomm.2020.00039

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. FDA-2022-E-3124 ).

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PEMBlog

JULY 17, 2023

18, 2014, doi:10.1056/nejmvcm1207131. 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. 11, 2009, pp.

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FDA Law Blog

JUNE 14, 2022

Though Esai’s Fycompa was initially approved in October 2012, it wasn’t scheduled until January 2014, meaning that Esai lost a little more than a year of patent life awaiting scheduling—in addition to the time spent in regulatory development and review. This is because, FDA explained, “ liberal does not mean unfettered.”

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FDA Law Blog

APRIL 3, 2023

In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder. The amount of the additional rebate is the excess (if any) of a drug’s current Average Manufacturer Price (AMP) over the inflation-adjusted AMP for a statutorily specified baseline quarter. NDA or BLA) drugs. times that of Medicaid ( $98 billion and $38.1

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FDA Law Blog

MAY 7, 2025

On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS. Sorenson follows the Fifth Circuits decision last year in United States v. Medicare or Medicaid). In contrast to its decision in United States v.

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FDA Law Blog

JUNE 23, 2021

I have been boots on the ground in watching the culture shift both within FDA and in industry, as the value of the patient voice has been recognized as legitimate. I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints.

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FDA Law Blog

FEBRUARY 27, 2024

In September 2014—nearly ten years ago!—PTE 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. § But there are still a couple of possibilities lurking out there! The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s RE 44,599 and U.S.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

SEPTEMBER 29, 2021

By 2014, the HHS Office of Inspector General (“OIG”) found that the rise of contract pharmacy arrangements resulted in duplicate discounts and drug diversion, and a lack of access to 340B pricing at the contract pharmacies. HRSA based its opinion on the statute and agency precedents over the last 25 years.

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FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. Policies and Procedures. Accountability Audit.

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