IT and 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 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

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

Sound Physicians

APRIL 28, 2025

While we’ve earned our reputation over the decades for our clinical excellence in hospital medicine , we’ve also earned — somewhat unfairly — a reputation for being more expensive than our competitors. On the face of things this may seem true, but I’d like to show you why we’re actually the most sustainable when it comes to your bottom line.

IT

IT Hospital Telemedicine Clinic

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

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. By John W.M. The report stated that OPQ performed 359 expedited quality assessments to address shortages.

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. A replication competent lentivirus (RCL) testing exemption can be requested after you’ve obtained several lots showing that you can repeatedly generate RCL negative drug product.

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. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

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. before evaluating clinical effectiveness).

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. Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The Notice of Proposed Rulemaking (NPRM) for LDTs is scheduled to be published in the Federal Register in August. Of course, the rulemaking process has its own uncertainties.

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. bioeconomy.” The first goal under Theme 1—Goal 1.1—is

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

A driver behind these changes is the “One Big Beautiful Bill,” the name given to spending and tax legislation designed to advance the policy agenda of President Donald Trump. It passed the House on May 22 and is pending in the Senate. Here are four key ways Trump’s policies could undermine Obamacare enrollment and coverage.

Insurance

Insurance Families Family Government

Primary Care Digest

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

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

Trending Sources

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

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

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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