The Direct Doctors Difference

DECEMBER 8, 2023

A recent article featured on the medical blog, www.Kevinmd.com , highlights some super important reasons as to why you might consider seeing a doctor who is not affiliated with a hospital or large system. In addition, when patients have testing done at in-hospital labs and facilities, the costs are higher than stand-alone centers.

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FDA Law Blog

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

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Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. These professionals play a vital role in maintaining essential services and ensuring continuity of patient care.

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FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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ABIM

JUNE 12, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The following is a summary of the spring meeting.

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Priority Physicians

JANUARY 20, 2025

But if you’re a patient of a direct primary care (DPC) practice , you don’t need to guess about orthopedic pain management. Unfortunately, traditional care doctors often resort to the two easiest options for patients with joint or back pain: They send the patient for imaging or refer them to a specialist.

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Management Primary Care Physician Primary Care Patient-Centered 52

FDA Law Blog

OCTOBER 14, 2024

California Stem Cell Treatment Center, Inc., 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. Stem Cell Clinic, LLC , 998 F.3d

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Clinic Patient-Centered Asthma Patients 59

Vascular Physician

OCTOBER 26, 2021

What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. Most patients lie on their backs or sit up just slightly.

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Patient-Centered Diabetes Treatment Plan Insurance 52

FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. The Court held that it does.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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FDA Law Blog

JUNE 3, 2025

Houck We appreciate receiving feedback on our blog posts. tablets to patients over the course of many months. CDC Clinical Practice Guideline for Prescribing Opioids for Pain United States, 2022 , 71 MMWR Recomm. By Larry K. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec. and tramadol 50 mg. at 50,374-75 n.18.

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FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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FDA Law Blog

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

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. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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FDA Law Blog

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. While desirable for patients, validation on multiple platforms can lead to challenges.

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Clinic Patient-Centered Medical IT 59

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog.

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FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. The notice was given to Acceleron Pharma, Inc., National Library of Medicine. 42 U.S.C. §

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Clinic Patient-Centered IT Provider 52

PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

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Family Families Hospital Patient-Centered 101

FDA Law Blog

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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FDA Law Blog

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. We have blogged about this controversy in previous posts (see e.g., here and here ).

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FDA Law Blog

OCTOBER 11, 2022

Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year. Sasinowski & James E.

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Clinic Provider IT Patient-Centered 61

FDA Law Blog

APRIL 10, 2023

Booker opined that the Act would expedite rescheduling schedule I substances that receive breakthrough therapy designation to schedule II that “with DEA oversight-will enable patient access and reduce the burden on further clinical investigation.” Mace cited recent research in the U.S. Mace cited recent research in the U.S.

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Patient-Centered Mental Health Medical Clinic 59

FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. The EKRA issue in this case centered on how Graves was compensated.

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FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. The notice was given to Acceleron Pharma, Inc., National Library of Medicine.

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Clinic Patient-Centered IT Provider 40

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

OCTOBER 10, 2023

Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades. She completed her residency and a fellowship in medical oncology/hematology at Brown University, Roger Williams Medical Center, and Brown University Affiliated Hospitals.

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Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

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FDA Law Blog

SEPTEMBER 23, 2022

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

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FDA Law Blog

APRIL 13, 2025

LYTGOBI was granted accelerated approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or rearrangements. Join us as we break down what went wrong this time. What Happened? The problem? As a single-arm trial (i.e.,

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Provider Healthcare Professional Patient-Centered Clinic 52

FDA Law Blog

DECEMBER 15, 2024

If you make a tissue product you may produce one lot per patient where a gene therapy may only need a handful of lots through Phase 3. This is even more so in rare disease CGT programs where clinical development can be more streamlined, so CMC product development is expected to happen at a more rapid rate.

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware.

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