Plum Health

MAY 19, 2023

Plum Health DPC has a primary care solution designed just for you: Embrace the Benefits of Direct Primary Care Direct Primary Care is a membership-based healthcare model that emphasizes a direct relationship between patient and doctor. Always consult with a healthcare professional for any medical condition or health concern.

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Noreta Family Medicine

FEBRUARY 12, 2025

The film talks about some of the escape fires of healthcare, including non-opioid pain treatments, nutrition programs, strong doctor-patient relationships, among others. As I learned, an “escape fire” is a firefighting technique, used while fighting particularly dangerous wildfires. One study showed that the average primary care visit is 18.9

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Priority Physicians

JANUARY 27, 2025

It may affect your performance and relationships. Pursue supportive relationships: We’re social beings. We all want to know how to stop fearing the future. Although anxiety appears to be the new malady du jour , much of it is natural and normal. Sometimes, it’s even protective. Ask an 80-year-old to define the best part of their life.

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FDA Law Blog

NOVEMBER 14, 2024

That he is now being quoted in a blog post to discuss the relationship between medical device companies and their regulatory oversight body shows that some ideas really do have staying power. If you can establish a positive working relationship with the review team, you may conclude that FDA is a friend.

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Family Physicians of Greeley

MAY 17, 2023

In this blog, we will explore effective strategies for improving mental health and nurturing a positive mindset. Cultivate Supportive Relationships: Building and maintaining healthy relationships is essential for our mental well-being. Maintaining good mental health is essential for our overall well-being.

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Noreta Family Medicine

MARCH 20, 2024

You need to be able to trust your doctor and build a relationship with them. After all, you will be going to this doctor to discuss almost all of your health needs and concerns (at least initially!). Experienced? Look at positive online reviews to see if those qualities are mentioned. Take negative reviews with a grain of salt!

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Vascular Physician

APRIL 22, 2024

Prevention begins with understanding the relationship between these two conditions. Understanding High Blood Pressure High blood pressure, or hypertension, is a common medical condition in which blood pressure flows through the arteries with a force that is consistently higher than normal. And when it occurs, the results can be fatal.

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GeriPal

MAY 19, 2022

Summary Transcript Summary. A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). How do you do that? Do you do what I do, pull out a handy-dandy opioid equianalgesic table to give you a guide on how much to convert to? . which advocates for an updated, wait for it… equianalgesic table! . Drew: Yeah.

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FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.

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FDA Law Blog

OCTOBER 2, 2023

Several of these approvals, including examples in which we were directly involved—Relyvrio for ALS and Skyclarys for Friedreich’s Ataxia—expanded upon the examples FDA previously provided to illustrate their interpretation of the single study plus confirmatory evidence statutory standard (see our earlier blog posts here and here ).

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Reflections of a Grady Doctor

JUNE 30, 2022

What if he fully equipped you with confidence and enough self-love for meaningful adult relationships through his exemplary love of your mother, his siblings, his cousins, and countless lifelong friends? I knew that it would be important for me to share this news here since so many of you grew to know and love him through this blog.

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FDA Law Blog

MAY 10, 2023

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. effective May 12, 2023 through November 11, 2024, Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023. By Karla L.

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Priority Physicians

FEBRUARY 3, 2025

At Priority Physicians, your relationship with your primary care doctor encourages openness on this subject. MORE BLOGS ← PREVIOUS NEXT → Learn more about membership with Priority Physicians For more details on our services and the concierge care we provide to our members, contact us today. What Does THC Do?

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FDA Law Blog

JUNE 8, 2023

CDRH As of this blog post, CDRH has not made any official announcements regarding the resumption of in-person meetings. Advisory Committee Meetings As of this blog post, all Advisory Committee Meetings that FDA has announced will be conducted via an online platform.

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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

NOVEMBER 28, 2023

The timing of this meeting has certainly raised more than a few eyebrows, particularly given its relationship to the proposed LDT rule (see our prior posts here , here , and here ). By Allyson B. Mullen & Jeffrey N. Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic.

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FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Law Blog

MAY 9, 2023

As FDA continues to both build its cybersecurity and digital health infrastructure and strengthen its cross-agency relationship with FTC, we can’t help but wonder how soon we’ll see an action like this against a device company. Kochava decided to strike first and sued the FTC , hoping to preempt the pending enforcement suit.

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FDA Law Blog

MAY 27, 2024

Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Hyman, Phelps & McNamara, P.C. HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice.

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FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. The practice of medicine was viewed as paternalistic.

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FDA Law Blog

JULY 7, 2021

Walsh & Jeffrey N. Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. FDA cleared 510(k)s for GEDs in the 1990s. In April 2020, JRC and the parents and guardians of its patients petitioned the D.C.

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FDA Law Blog

JUNE 1, 2021

Meetings in person allow for the pre- and post-meeting informal exchanges that help to build collegiality and good working relationships. But it’s just not the same. The opportunity to observe body language is, as MasterCard would say, priceless.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. S&G Labs has no contractual relationships with the entities that referred clients to S&G Labs. EKRA is codified at 18 U.S.C. § Until recently, no federal court had had occasion to interpret EKRA. 18 U.S.C. § 24(b) (emphasis added). EKRA is also a new law and the U.S.

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FDA Law Blog

MARCH 7, 2022

We urge FDA to clarify the relationship of this policy and the proposed transition plan in the final guidance. The draft guidance proposes a 180-day transition period from the implantation date (the “Transition Period”) for devices marketed under the enforcement discretion policies identified specifically in the draft guidance.

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FDA Law Blog

DECEMBER 12, 2022

intrusion [into] the doctor-patient relationship. Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The draft guidance purports to apply to current PMA holders.

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FDA Law Blog

OCTOBER 14, 2021

The Federal Food, Drug, and Cosmetic Act states that nothing in the Act shall “limit or interfere with” the authority of a clinician to utilize any legally marketed device on a patient “for any condition or disease within a legitimate health care practitioner patient relationship.” operative performance and perhaps acute outcomes.

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FDA Law Blog

SEPTEMBER 6, 2022

For example, the Draft Guidance includes answers to general questions about the intended timeframe for response to charging requests (30 days), who should request FDA’s authorization to charge (the IND sponsor), and whom the sponsor may charge with this authorization (not FDA’s business).

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FDA Law Blog

JULY 5, 2023

While section 503B expressly does not require a patient-specific prescription, FDA clarifies that Congress evidently did contemplate a “connection” (our words…) between an outsourcing facility and the prescriber; the more attenuated that relationship, the more an outsourcing facility starts to resemble a conventional drug manufacturer.

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FDA Law Blog

FEBRUARY 27, 2023

180 days past May 11, 2023) for those telemedicine relationships established during the COVID-19 emergency. within 30 days) in the doctor-patient relationship. For both proposed rules, the bottom line is that, while telemedicine is here to stay, circumstances permitting it are indeed not limitless.

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PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Topics covered include: The pathophysiology of GER and GERD in the pediatric population. Understanding dyspepsia and its clinical presentation. Diagnostic strategies and when to consider further evaluation.

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FDA Law Blog

FEBRUARY 14, 2023

Gaulkin & Riëtte van Laack — Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. By Sophia R.

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FDA Law Blog

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. S&G Labs has no contractual relationships with the entities that referred clients to S&G Labs. EKRA is codified at 18 U.S.C. § Until recently, no federal court had had occasion to interpret EKRA. 18 U.S.C. § 24(b) (emphasis added). EKRA is also a new law and the U.S.

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Pamela Wible MD

JUNE 20, 2025

Characterized by cynicism, exhaustion, and reduced job satisfaction, physician burnout can lead to devastating personal and professional consequences, including strained relationships, substance abuse, early retirement, and even suicide. It’s a growing crisis affecting over half of all doctors in the U.S., They’re suffering from moral injury.

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Doctor Rachel

NOVEMBER 21, 2022

See my blog Sweet Dreams for help with sleep strategies. leave the destructive relationship, don’t see unhelpful friends, find a new job, stop the addiction, get out of the house, get off of social media (it increases depression). We live in a culture with unrealistic and harmful ideas that we should be perpetually happy.

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Adventures of a Sick Doctor

JUNE 5, 2021

I've been neglecting this blog. My wonderful GP has died, but I am building a relationship with my new one. I write a column in a medical newspaper every couple of months, and that absorbs my writing energy. The CEO, Susan Clyne, began to present the findings from a recent survey about doctor’s wellbeing. I went back to the Red Door.

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Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Preventive care is often referred to as the first line of defense in healthcare—and for good reason. What Is Preventive Care?

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