2019, Manufacturing and Medical - Primary Care Digest

9 Technologies That Will Shape The Future Of Dentistry

The Medical Futurist

JUNE 17, 2025

Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells.

Patients

Patients Treatment Plan Healthcare Medical Specialty

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.

Manufacturing

Manufacturing Medical Government IT

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

Manufacturing

Manufacturing Provider Medical IT

Buyer beware: 60% of foods purchased by Americans contain technical food additives, a 10% increase since 2001

Medical Xpress

MARCH 13, 2023

The findings also present compelling evidence that the prevalence of food additives is on the rise; manufacturers have increased the mean number of additives contained in purchased food and beverage products from 3.7 in 2019. This represents a 10% increase since 2001. in 2001 to 4.5

Manufacturing

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA Law Blog

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. FDA, Guidance for Industry, The Special 510(k) Program (2019). By Adrienne R. Comments on the Draft Guidance may be submitted until November 20, 2024.

Medical

Medical Specialization Manufacturing IT

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing

Manufacturing Hospital Healthcare Medical

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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 ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients

Patients Clinic Medical Patient-Centered

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law Blog

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000.

Hospital

Hospital Manufacturing Specialization Medical

510(k) Modernization 2023

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.

Medical

Medical Electronics Manufacturing Utilities

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.

Manufacturing

Manufacturing Patient-Centered Healthcare Utilities

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic

Clinic Medical Provider Patients

Estimating Risk Associated with Medical Device Malfunctions: FDA’s Warning letter to Medtronic Highlights an Under Appreciated Potential Source of Error in the Estimation

FDA Law Blog

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. During an inspection, FDA learned that Medtronic had opened a CAPA to address complaints of damaged retainer rings in these pumps (more than 74,000 between June 2016 and November 2019, with more than 57,000 reported to FDA as MDRs).

Medical

Medical Management Manufacturing Patients

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

OCTOBER 14, 2021

As a scientific/medical matter, there are many variables beside the RAS device that are responsible for clinical outcomes. FDA issued the same type of warning regarding RAS devices and mastectomy back in February 2019 suggesting that FDA believes the problem has persisted. But these devices are not independent cancer therapeutics.

Patient-Centered

Patient-Centered Healthcare Provider Manufacturing

Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device

FDA Law Blog

APRIL 19, 2021

Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device.

Manufacturing

Manufacturing Government Medical IT

Attorney General Garland: Marijuana Enforcement Remains Low DOJ Enforcement Priority in States Where Activity Is Legal

FDA Law Blog

MAY 2, 2022

Marijuana is legal for medical use in 37 states, and for recreational use by adults in 18 states, but the drug remains a federal schedule I substance. They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. 15 and 16, 2019). 21 U.S.C. § 812(c)(10). 21 U.S.C. §

Manufacturing

Manufacturing Medical IT Community

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog

OCTOBER 14, 2024

HTC/Ps in this last category are regulated as drugs or medical devices under the FDCA, or biological products under section 351 of the PHSA, which typically require premarket approval and compliance with the full panoply of FDA regulation. 588, 566 (2019)). Robbins , 519 U.S. 452 (1997); see also Kisor v. Wilkie , 588 U.S.

Clinic

Clinic Patient-Centered Asthma Patients

An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

JUNE 19, 2025

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary.

Insurance

Insurance IT Board-Certified Medical

Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison Time Stamps 00:00 Opening 00:45 Introductions 03:07 Guest Introduction 1 04:46 Guest Introduction 2 08:15 On the Intersection of Black, Fat, and Trans Communities and the Medical-Industrial Complex 13:35 History and the Racial Underpinnings of Food Shaming in the U.S. Episode Takeaways Origin Stories – For Dr. Psyche A.

Community

Community Manufacturing Patients Medical

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder.

Patient-Centered

Patient-Centered IT Healthcare Medical

Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

FEBRUARY 15, 2025

It also does not change the context that most patients overestimate drug safety and that the most heavily advertised drugs have lower added benefit compared with similar medications. Kennedy, Jr.’s s previously stated intention to ban DTCA from television.

Family Physician

Family Physician Manufacturing Family Families

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. So medication adjustments.

Illness

Illness IT Patient-Centered Patients

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing

Manufacturing Vaccination Government Diagnosis

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

Manufacturing

Manufacturing Consulting Healthcare Professional IT

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

FEBRUARY 4, 2025

As our readers may already know, FDA maintained three PRV programs to incentivize the development of therapies for underfunded diseases: the RPD PRV program, which sunset last month, the Medical Countermeasures (MCM) PRV Program, which sunset in October 2023, and the Tropical Disease PRV Program.

IT

IT Vaccination Manufacturing Medical

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 23,711 (June 4, 2025).

Specialization

Specialization Manufacturing Electronics PCP

Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

OCTOBER 17, 2021

Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). It is worth noting that Covaxin, our indigenously developed vaccine manufactured by Bharat Biotech, is on the verge of getting approval in the pediatric age group as well (6). Arsenic Toxicity 8.

Vaccination

Vaccination Government IT Clinic

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

FDA Law Blog

SEPTEMBER 8, 2022

Recognizing the problems that high prescription drug costs pose to patient access to medications, many drug manufacturers have created copay assistance programs to help patients afford the copays and deductibles for their medications. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance

Insurance Patients Manufacturing Patient-Centered

Planning for the End of the COVID-19 Public Health Emergency

FDA Law Blog

OCTOBER 14, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. We’re still doing a lot of work on it.

Medical

Medical Provider Manufacturing Complication

Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA!

FDA Law Blog

MAY 8, 2025

Claud On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made. In a recent Executive Order (E.O.)

Manufacturing

Manufacturing Government Physicals Medical

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law Blog

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) it is illegal to import.

Manufacturing

Manufacturing IT Individual Provider

Primary Care Digest

9 Technologies That Will Shape The Future Of Dentistry

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

Trending Sources

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Buyer beware: 60% of foods purchased by Americans contain technical food additives, a 10% increase since 2001

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

510(k) Modernization 2023

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

Estimating Risk Associated with Medical Device Malfunctions: FDA’s Warning letter to Medtronic Highlights an Under Appreciated Potential Source of Error in the Estimation

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

Big Win for HP&M Client: Court of Appeals Tells FDA to Regulate Barium Sulfate As a Device

Attorney General Garland: Marijuana Enforcement Remains Low DOJ Enforcement Priority in States Where Activity Is Legal

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

An Arm and a Leg: The Prescription Drug Playbook, Part I

Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA-Approved Labeling: Is Enough Enough?

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

Arsenicum album for Kerala school students: a bogus prophylaxis

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

Planning for the End of the COVID-19 Public Health Emergency

Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA!

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

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