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Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device.

Medical

Medical Manufacturing Electronics Provider

The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

Manufacturing

Manufacturing IT Provider ER

FDA’s Vape Ban Hits the Right Note: Supreme Court Says “Let It Be”

FDA Law

APRIL 6, 2025

This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

IT

IT Manufacturing Provider Family

Maine and Nevada Update Drug Price Transparency Laws

FDA Law

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

Manufacturing

Manufacturing Asthma Diabetes Family

PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

Specialization

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It’s a Bird, It’s a Plane, It’s Operation Stork Speed

FDA Law

MARCH 30, 2025

This initiative seeks to address the ongoing challenges families face in ensuring they have access to safe, reliable, and nutritious infant formula and is described by HHS Secretary Kennedy as critical to the pursuit of Make America Healthy Again.

Families

Families Family Manufacturing Provider

Common Skincare Ingredients that Are Linked to Cancer

Health One Family Medicine

APRIL 30, 2021

As with parabens, manufacturers add them to reduce the risk of bacterial contamination. Be Smart With Your Beauty Products At Health One Family Medicine , we always place more emphasis on overall wellness, since a healthy body will automatically look beautiful. You can find triclosan in body washes, toothpaste and antibacterial soaps.

Family Medicine Practitioner

Family Medicine Practitioner DO Family Medicine Family

This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

FDA Law

NOVEMBER 22, 2022

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S.

Supply Chain

Supply Chain Illness Family Families

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

Common Sense Family Doctor

FEBRUARY 15, 2025

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. Kennedy, Jr.’s

Family Physician

Family Physician Manufacturing Family Families

Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law

MAY 15, 2025

Stage IV cancer should not be approved like a cosmetic, he quipped, quickly calling to mind his days as an oncological surgeon and the many difficult conversations he had with patients and families with very limited options. Industry can, however, expect smarter tailoring of regulatory frameworks by condition, product type, and risk.

Manufacturing

Manufacturing Vaccination Illness IT

FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

FDA Law

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” On January 28, 2021, the judge in that case ordered the agency to respond to the petitioners by April 29, 2021.

IT

IT Manufacturing Specialization Community

FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

FDA Law

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” On January 28, 2021, the judge in that case ordered the agency to respond to the petitioners by April 29, 2021.

IT

IT Manufacturing Specialization Community

Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule

FDA Law

JUNE 27, 2022

Kirschenbaum — We have blogged before (for example, here and here ) on amendments to the Federal health care program antikickback law safe harbor regulations that were finalized by the Trump Department of Health and Human Services in November 2020.

Finance

Finance Government Manufacturing Community

Primary Care Digest

Is my Software a Medical Device? Use the Digital Health Policy Navigator

The Most Engaging Decision You’ll Read All Year – Five Stars

Trending Sources

FDA’s Vape Ban Hits the Right Note: Supreme Court Says “Let It Be”

Maine and Nevada Update Drug Price Transparency Laws

PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

It’s a Bird, It’s a Plane, It’s Operation Stork Speed

Common Skincare Ingredients that Are Linked to Cancer

This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

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

Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule

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