FDA Law Blog

AUGUST 15, 2021

Thus ends a saga that began with a proposal in 2015 to amend the “intended use” regulation. This set off a firestorm, eventually leading to a new proposed rule in 2020, which was much closer to the one in 2015. This set off a firestorm, eventually leading to a new proposed rule in 2020, which was much closer to the one in 2015.

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Manufacturing IT Provider Government 93

Louisville Lectures

MAY 5, 2023

These lectures will be provided by the University of Louisville Internal Medicine residents. Disclaimers ©2015 LouisvilleLectures.org Visit the IMLS Series Little Lectures Little Lectures is an under ten-minute video series created by residents for learners. Follow us on Instagram to follow us behind the scenes!

Internal Medicine 52

Internal Medicine Patient-Centered Education Hospital 52

Louisville Lectures

OCTOBER 5, 2018

These lectures will be provided by the University of Louisville Internal Medicine residents. Disclaimers ©2015 LouisvilleLectures.org We are excited to help expand the FOAMed movement into internal medicine where so much work has been done by various medical education programs. "I Visit here.

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Internal Medicine Medical Student Education Specialization 52

The Clinical Problem Solvers

JUNE 26, 2023

Dr. Beach has won numerous awards for her scholarship and mentorship, including the David Levine Mentoring Award from the Johns Hopkins School of Medicine in 2015. Calac June 22, 2023 Summary : This episode highlights a selection of antiracism research presentations at a live recording of the podcast at the 2023 SGIM Annual Meeting.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

Physician's Weekly

JUNE 19, 2025

Gowin and his colleagues analyzed data from 1,003 adults between 22 and 36 years of age who had functional magnetic resonance imaging (fMRI), urine toxicology, and cannabis use results collected at one academic site between 2012 and 2015 as part of the Human Connectome Project. The cohort (mean age, 28.7

Community 52

Community Healthcare Diagnosis Medical 52

PEMBlog

OCTOBER 31, 2024

Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. N Engl J Med 2018; 379:2015-2026. N Engl J Med. 2018 Nov 22;379(21):2002-2014.

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FDA Law Blog

SEPTEMBER 30, 2022

Dunn suggested that we look to FDA’s previous approval decisions to understand just how much uncertainty can be accepted, sighting in ALS to previous approval decisions that did not provide traditional efficacy evidence. By Frank J. Sasinowski & James E. We would like to acknowledge FDA for its efforts on this devastating condition, ALS.

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Community Provider Patients Specialization 98

Doctor On Demand

APRIL 16, 2025

For more severe symptoms, in-person care may be the recommended course of treatment, and your virtual provider can help you make that decision. If your symptoms indicate more serious problems, the telehealth provider may refer you for in-person care or testing. You should never ignore chest pain or chest soreness with congestion.

Medical 52

Medical Board-Certified Asthma Telehealth 52

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Interconception Care for Primary Care Providers: Consensus Recommendations on Preconception and Postpartum Management of Reproductive-Age Patients With Medical Comorbidities. Health Equity Considerations in State Bills Related to Doula Care (2015–2020). During this episode, we hear from Dr. S. Zakaria, S., Vaught, A. Karbeah, J.,

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

FDA Law Blog

AUGUST 26, 2021

At a very general level, starting in 2015, in a high profile series of prosecutions, the DOJ accused a number of top FIFA officials of widespread criminal conduct. By JP Ellison — It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems.

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FDA Law Blog

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers. 6,708 (Feb.

Supply Chain 52

Supply Chain Provider Government Complication 52

33 Charts

OCTOBER 2, 2021

Inconsistency in care delivery So as every provider shapes her practice around MyChart, each will do it in a slightly different way. But this may not be consistently applied by other providers in the same group. Crucial that we fix this. And individual practice styles are fine. The problem comes with call and cross-coverage.

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Patients IT Provider Family Doctor 75

Louisville Lectures

OCTOBER 30, 2020

Wasn’t the stress of dealing with the COVID-19 pandemic enough, without having to adjust to a whole new system of interviewing for one of the most important positions in my career? It turns out, humans really are extremely adaptable. The process of virtual interviewing is far less intimidating than it seems to be. Time to interview!

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Screening IT Internal Medicine Medical 52

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).

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 21, 2021

You see, in 2015, FDA revised its 15-year old FDRR guidance document to exclude EOP2 disagreements from the FDRR process (i.e., We were so alarmed by the predicament created by the 2015 change to the FDRR guidance that we raised the issue in a comment to the docket. We observed.

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IT Specialization Provider Clinic 52

FDA Law Blog

SEPTEMBER 26, 2024

In particular, CDRH touts its Breakthrough Devices Program, which it advertises as a “program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough program started in 2015.

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Clinic IT Manufacturing Medical 64

FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. FDA-2022-E-3124 ).

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

AUGUST 11, 2024

FDA’s stated concern from a public health perspective is that the omission of risk information “fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety.” August 2024 Untitled Letter to Mirati Therapeutics Inc.

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Clinic Provider IT Complication 59

FDA Law Blog

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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IT Education Utilities Patient-Centered 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. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. 351, 355-56 (1985).

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Patients IT Provider Individual 59

FDA Law Blog

JUNE 23, 2021

This is why it is important for relevant patient populations to provide input as to what degree of certainty is needed for there to be a fair and reasonable conclusion of drug benefit for their condition. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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IT Clinic Provider Medical 52

FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

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Provider Individual IT Manufacturing 52

FDA Law Blog

MAY 25, 2022

The safety communication acknowledges that the tests “may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality.” However, even with a low PPV, a test can provide clinically useful information to providers and patients.

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Provider Screening Medical Patients 40

FDA Law Blog

JUNE 14, 2022

Because IRTNMTA pushed the approval date for controlled substances back to the date of DEA scheduling, Esai argued that the Fycompa date of approval should be pushed back, as its PTE application was pending at the time of the November 25, 2015 IRTNMTA enactment.

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IT Provider Medical 52

FDA Law Blog

JANUARY 31, 2022

Because Plaintiff has provided no notice to defendants, the Court is precluded from issuing any preliminary injunction. Because Plaintiff has provided no notice to defendants, the Court is precluded from issuing any preliminary injunction. Not quite yet, but maybe soon, as explained below. 21 U.S.C. § Complaint ¶ 38.)

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Government IT Provider Healthcare 40

FDA Law Blog

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The rule, when finalized, will replace existing 21 C.F.R. Part 205 (Guidelines for State Licensing of Wholesale Prescription Drug Distributors).

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

FDA Law Blog

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible. A December 2021 warning letter to Medtronic, Inc. Is FDA’s criticism valid?

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Medical Management Manufacturing Patients 40

CDOCS

MARCH 31, 2021

& Below, a breakdown is provided for the number of appointments needed in the analog workflow (three appointments) compared to the digital CEREC Primescan iJIG workflow (one appointment).& <em>Spear, </em>October 21, 2015.</span></span></span></li>

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Appointment Families Family Patients 52

Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. He has written a book, What’s Going on Down There?

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Patients Private Practice Management Healthcare 52

CDOCS

MARCH 26, 2021

png]<br /> <em><span style="font-size:11px;">​Figure& 1:& <span data-contrast="auto" xml:lang="EN-US">A life-long bruxer, this patient presented with lost teeth in the posterior and compensatory eruption of lower anterior teeth.</span>& png] [image:10.png]​<br

Families 52

Families Family Patients Provider 52

GeriPal

DECEMBER 15, 2022

Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. Summary Transcript Summary. But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). .

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IT Patient-Centered Healthcare Illness 106

GeriPal

JUNE 19, 2025

It was also the time that in 2015, that people who were trans and famous really put being trans on the map at that time, too. Eric and I remember him from that time and he’s now at the University of Nevada, Las Vegas, where he is associate professor in the department of social and behavioral health. Eric 04:53 How is it public?

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Individual Community IT Chronic Condition 82

GeriPal

MAY 18, 2023

We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. We discuss a little history of the Beers criteria, including the original Beers Criteria that was published by the late Dr. Mark Beers, and how it has evolved over the last three decades. Alex: We’re having Beers. We’ll learn about that.

Medical 97

Medical IT Patients Clinic 97

FDA Law Blog

FEBRUARY 7, 2024

According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions. 21 U.S.C. § Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped.

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Government Electronics Education Individual 116

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin). There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Tasce: I do. Tasce: Yes. Eric: Yeah.

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Patient-Centered IT Healthcare Medical 96

GeriPal

DECEMBER 8, 2022

Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? Here we go.

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