White Paper - Primary Care Digest

White paper recommends expanding endoscopic classification of esophagogastric junction integrity beyond hill grade

Medical Xpress

MARCH 3, 2023

A new white paper by the American Foregut Society recommends expanding the classification of the esophagogastric junction (EGJ) to increase an assessment of the axial hiatal hernia length, hiatal hernia aperture diameter, and presence or absence of the flap value, making it more comprehensive.

Medical

Medical IT

New white paper finds Medicare coverage for weight loss therapies could generate significant cost-offsets

Medical Xpress

APRIL 18, 2023

A new USC Schaeffer Center white paper finds the value to society of Medicare coverage for new classes of weight loss drugs would equal nearly $1 trillion over ten years.

New white paper offers solutions to ensure greater patient access to prescription drugs

Medical Xpress

APRIL 13, 2023

Although the Inflation Reduction Act of 2022 (IRA) aimed to increase patient access to prescription drugs and decrease spending, researchers warn that it may have unintended negative impacts on patients in the long run.

Patients

Patients IT Medical

Increasing cyber and ethical risks to safety means care homes' need for insurance protection is greater than ever

Medical Xpress

FEBRUARY 9, 2023

The cyber and ethical risks posed by telemedicine to care homes could outweigh its value unless safeguarding steps are taken, says a new white paper.

Telemedicine

Telemedicine Insurance IT Medical

Beware the bait-and-switch when it comes to HM program contracts

Sound Physicians

APRIL 28, 2025

Compared with industry-standard annual subsidy increases of between 4.2 percent and 5.7 percent, our average increase over five years is just 0.5 percent annually.

IT

IT Hospital Telemedicine Clinic

OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts

FDA Law Blog

APRIL 8, 2024

It also noted that last year, FDA hosted a two-day public workshop and published a white paper on the regulatory framework for Artificial Intelligence in drug manufacturing, in addition to other efforts. Like many of us, OPQ seems intent on trying to keep up with how technology can/will impact pharmaceutical quality.

Manufacturing

Manufacturing IT

Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

FDA Law Blog

NOVEMBER 1, 2022

Stay tuned for USP white paper(s) on the workshop’s discussion as well as USP information chapters on lenti-viral vector cell therapies. Overall, it appeared from the workshop discussions that potential standards relevant to CART cell therapies include particle size, particle number, for the cell line, and infectious titers.

Manufacturing

Manufacturing Clinic Provider IT

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law Blog

JANUARY 5, 2023

CDRH is building an extensive library of similar reports and white papers as it prepares its final guidance for medical device cybersecurity, scheduled to come out next Fall. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

Manufacturing

Manufacturing Engineering Clinic Provider

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

The final guidance does not provide further insight as to what other types of information would be considered “similar” in their level of independent verification and validation, but could be read to exclude any reports, such as sponsor white papers, that have not undergone third-party peer review.

Clinic

Clinic Medical Provider Patients

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Supply Chain

Supply Chain Manufacturing Government Hospital

FDA’s Summer Plans May Include LDT Rulemaking

FDA Law Blog

JUNE 19, 2023

See , e.g. , ACLA White Paper on LDTs here. Given the make-up of the House and the aversion to expansion of FDA authority, it seems extremely unlikely that the newest version of the VALID Act, which was introduced in March 2023, will advance in the next two years.

IT

IT Management Clinic Medical

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

FDA Law Blog

JANUARY 24, 2024

in 5 Years.” As discussed in the new report, producing 25% of all APIs for small molecule drugs within 5 years is an achievable goal: To achieve this goal, this white paper proposes API manufacturers adopt advanced manufacturing technologies provisioned through public incentives.

Supply Chain

Supply Chain Manufacturing Government Provider

Four Ways Trump’s ‘One Big Beautiful Bill’ Would Undermine Access to Obamacare

Physician's Weekly

JUNE 12, 2025

.” It can take up to six weeks for the Social Security Administration to process a number for a newborn, and an additional two weeks for parents to get the card, according to a white paper that analyzed provisions of the House bill and was co-authored by Jason Levitis, a senior fellow at the Urban Institute, and Christen Linke Young, a visiting (..)

Insurance

Insurance Family Families Government

Primary Care Digest

White paper recommends expanding endoscopic classification of esophagogastric junction integrity beyond hill grade

New white paper finds Medicare coverage for weight loss therapies could generate significant cost-offsets

Trending Sources

New white paper offers solutions to ensure greater patient access to prescription drugs

Increasing cyber and ethical risks to safety means care homes' need for insurance protection is greater than ever

Beware the bait-and-switch when it comes to HM program contracts

OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts

Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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

Does the Drug Shortage White Paper Fall Short?

FDA’s Summer Plans May Include LDT Rulemaking

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

Four Ways Trump’s ‘One Big Beautiful Bill’ Would Undermine Access to Obamacare

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