Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation.

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Putting Patients First Blog

APRIL 8, 2025

NHC Submits Comments on FDA Draft Guidance for AI/ML-Enabled Medical Devices (PDF) April 7, 2025 Dockets Management Staff U.S. Sponsors must also communicate how patient data are collected, processed, and used throughout the AI lifecycle, ensuring transparency and maintaining public confidence.

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Putting Patients First Blog

JANUARY 10, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers. The following is an overview of the NHC’s comments on proposals in the 2025 NBPP.

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Putting Patients First Blog

APRIL 7, 2025

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. 12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier.

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Putting Patients First Blog

JANUARY 22, 2024

However, content must be presented in a clear and easily accessible way using plain language that is easy to understand and effectively communicated. There are customizable health literacy checks content developers can include when reviewing their documents. Other Blogs: What is Health Literacy and Why is it Important?

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Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Created by and for patient organizations more than 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy.

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Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Created by and for patient organizations more than 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy.

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Ramblings of a pharmacist

SEPTEMBER 26, 2023

As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. The communications I have seen and heard from the big 3 to small dispensers are irresponsible and seem like attempts to sabotage compliance, in my view.

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Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. 10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes.

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Putting Patients First Blog

MARCH 13, 2025

Webinar Recap: Navigating Compliance & Communication Challenges in the Current Environment March 13, 2025 By Randall Rutta, Chief Executive Officer & Micah Nation, Director, Executive Office In todays shifting political environment, nonprofit organizations are facing an evolving landscape of compliance and communications challenges.

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FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. 803), Reporting of Corrections and Removals (21 C.F.R. §

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European Pharmaceutical Review

APRIL 14, 2025

In the UK, the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 1 have passed through the UK legislative procedure and will apply from 23 July 2025. Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer.

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ID Stewardship

APRIL 13, 2023

The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here.

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European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Internet] WHO. cited 2023July]. Available from: [link] WHO.

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FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Some unanswered questions remain.

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Putting Patients First Blog

SEPTEMBER 9, 2024

Conclusion The NHC appreciates the opportunity to provide input on the CY 2025 OPPS proposed rule. amazonaws.com/s3fs-public/documents/Update_HHS_Disparities_Dept-FY2020.pdf Retrieved from https ://www.cms.gov/files/document/quality-motion-cms-national-quality- strategy.pdf 8 James, C., The Lancet , 389(10077), 1453-1463.

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Putting Patients First Blog

SEPTEMBER 9, 2024

CY 2025 PFS proposed rule). The continuation of audio-only communication options remains essential. These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer.

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Putting Patients First Blog

MARCH 24, 2025

Guest Blog: Navigating the AI Revolution: Patient-Centered AI Use in Health Care March 24, 2025 By: Allison Isaacson, MPH and Rachel Dungan, MSSP, AcademyHealth Artificial intelligence (AI) holds immense potential for enhancing and modernizing health care , with many use cases from interpreting x-ray results to personalizing treatment regimens.

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Express Pharma

JUNE 11, 2025

We have also extended our model beyond human APIs by now actively entering veterinary APIs with about 10 products in the pipeline for 2025. We are currently at consolidated annual revenues of Rs 419 crores as of March 2025, with a seven year CAGR of 75 per cent. Even more significant, we communicate actively with customers.

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Putting Patients First Blog

FEBRUARY 11, 2025

The NHC also emphasizes the importance of clear communication and transition planning to minimize disruptions. The NHC encourages CMS to provide regular updates on guidance documents and implementation progress to keep stakeholders informed and responsive to emerging challenges.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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FDA Law Blog: Biosimilars

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.) 62,094, 62,097 (Oct.

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FDA Law Blog: Biosimilars

MAY 23, 2025

The RFI reinforces Trumps January 31, 2025 executive order indicating that for every new regulation introduced, at least ten existing regulations must be eliminated (the 10for-1 Rule). Industry relies on guidance documents to understand the Agencys current policy and practice. The RFI is open through July 14, 2025.

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