Physician's Weekly

JUNE 24, 2025

Dr Vinson: I introduced the phrase in a 2020 essay I published after our initial 2016 case report. Vinson, MD , Kaiser Permanente Adjunct Investigator, Emergency Physician, and Research Chair, discussed his research team’s findings with Physician’s Weekly ( PW). PW: Who coined the term “cold drink heart”? Our study was relatively small.

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FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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Physician's Weekly

JUNE 24, 2025

Dribin, MD , of Cincinnati Children’s Hospital Medical Center, and study coauthors. “We We need to ensure efficient throughput to allow us to provide access to as many patients as we can,” said David Schnadower, MD, MPH, of Cincinnati Children’s Hospital Medical Center in a news release. “An

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FDA Law

OCTOBER 9, 2022

As of earlier this year , 37 states and the District of Columbia have legalized marijuana for medical use and 19 states and the District of Columbia have legalized cannabis for adult recreational use. HHS has undertaken scientific and medical evaluations of marijuana in recent years.

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Medi-Cal Minimum Medical Loss Ratio – Increases the minimum medical loss ratio for managed care plans, commencing January 1, 2026. This means patients will no longer be automatically grandfathered in for medications that are not on—or are removed from—the Medi-Cal Rx Contract Drug List (CDL).

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FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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Physician's Weekly

JUNE 24, 2025

So, in 2016, she celebrated her 60th birthday at her local CVS. Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. “I was there when they opened,” Beckham recalled.

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FDA Law

APRIL 25, 2023

Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e., Software in a Medical Device, or SiMD). Therefore, a firm should first determine whether its product meets the statutory definition of a medical device. This provision became effective as of March 29, 2023.

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FDA Law

FEBRUARY 26, 2024

Koblitz & Kurt R. Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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Medical Xpress

APRIL 18, 2023

According to a study published in 2017, 12% of the world's adult population was affected by obesity in 2016, double the percentage from 30 years earlier. Obesity and its associated cardiometabolic issues are a major health concern in the U.S. and internationally.

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FDA Law

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. By Larry K. Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020.

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Tiny Physician

AUGUST 12, 2021

As a person who spent almost a decade at medical colleges, I have heard numerous sexist comments from the faculty regarding the dressing sense of their students. My time at a North Indian medical college didn’t expose the dark side of such oral codes; however, in Kerala, I experienced such medieval customs and traditions.

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FDA Law

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

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FDA Law

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. and lack accepted safety for use under medical supervision. 812(c)(c)(10). 21 U.S.C. §

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PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Children’s Mental Health Emergency Department Visits: 2007-2016. Government. Pediatrics.

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FDA Law

JUNE 3, 2025

We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice. Recommendation 1. at Background.

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FDA Law

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making. The new § 820.10

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FDA Law

APRIL 22, 2024

When DEA denied marijuana rescheduling petitions in August 2016, cannabis was listed as a schedule I and schedule IV substance under the Single Convention. . § 811(d) required classification of marijuana as a schedule I or II substance to comply with U.S. 811(d) and U.S. treaty obligations, and, if not, why has DEA’s position changed?

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FDA Law

APRIL 11, 2022

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). This estimation of risk is important because it drives both decision making and regulatory compliance.

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FDA Law

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.

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FDA Law

MARCH 6, 2022

The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems. This international standard is the 2016 edition of ISO 13485, issued by the International Organization for Standardization (ISO).

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FDA Law

JUNE 14, 2022

Even a month of market exclusivity is financially lucrative enough to fight for, so it is no surprise that a company would go to the mat for an extra 13 months of patent exclusivity. Plain language, FDA explained, “evinces clear intent that it applies only to drugs scheduled after enactment.”

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FDA Law

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.

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FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

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FDA Law

APRIL 20, 2021

Medical Device Data System. Medical Image Storage Device. Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Medical Image Communications Device.

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FDA Law

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.

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FDA Law

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions.

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Integrated Care News by CFHA

MARCH 27, 2025

When the film is a documentary, such portrayal is also revealing, as is the case with “Fire at Sea,” directed by Gianfranco Rosi in 2016. A scene shows Samuele making slingshots from sticks he collects and medical rubber bands and then taking them to a local field to shoot projectiles at cactus plants with his friends.

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FDA Law

MAY 31, 2021

According to PhRMA, CMS recognizes that patient savings programs help patients afford necessary medications and stay on them, compl. ¶¶ 37, 41, and that accumulator programs dilute the benefit of such assistance and hurt the patient. CMS Proposes to Extend Effective Dates of Two MDRP Regulations. See our summary at 2-4.

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FDA Law

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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FDA Law

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. It harkens to the paternalism in medicine of the past.

Patients 52

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FDA Law

APRIL 13, 2021

This was the strategy employed when the emergency was declared for the Zika virus back in August 2016. The declaration of a public health emergency was not made until January 31, 2021. The first EUAs were starting to trickle in during the beginning of February so it is expected that the first month of the pandemic shows slow progress.

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FDA Law

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision. DEA and HHS last considered rescheduling cannabis in 2016. 21 U.S.C. § 53,688 (Aug.

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FDA Law

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 2016 Guideline. Purpose of the Proposed Guideline.

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BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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