Putting Patients First Blog

JANUARY 22, 2024

There are customizable health literacy checks content developers can include when reviewing their documents. Users simply upload their document directly into the Clear-AI digital platform and receive suggested feedback and readability scores on their respective content. Other Blogs: What is Health Literacy and Why is it Important?

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Documentation Communication Hospitals 40

European Pharmaceutical Review

JANUARY 13, 2023

Priorities for 2022-2025. Approval of the Guide on the declassification of documents pertaining to the work of the Ph. The Commission stated it will begin reflecting on how to address the issue of nitrosamine control in individual monographs. Appointment of 886 experts from Ph. and non-Ph. The post Ph.

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Documentation Vaccines 91

pharmaphorum

NOVEMBER 24, 2022

“The aim is that by 2025 DARWIN EU will deliver approximately 150 real-world evidence studies per year,” it added. . “These studies mark the start of a rapid ramp-up in the number of studies conducted to support regulatory decision making,” said the EMA in a statement.

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Documentation Hospitals 52

Pharma in Brief

JANUARY 10, 2024

The amendments are scheduled to come into force no later than January 1, 2025. The Court now requires a declaration identifying documents with AI-generated content that are prepared for the purpose of litigation and submitted to the Court. Canada’s new PTA system will come into force on or before January 1, 2025.

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Drug Pricing Documentation Biosimilars Vaccines 52

pharmaphorum

APRIL 16, 2021

NICE noted in its guidance document that “patient experts explained that the fortnightly infusions make it difficult for people to work, socialise and join in with family life.” Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for an eight-week dosing schedule after a loading phase.

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Biosimilars Documentation 52

pharmaphorum

JULY 4, 2022

Part of the plan includes a pledge to “streamline and strengthen the regulatory environment to ensure faster approval, set-up and delivery of studies,” according to the new document, which also points to increased investment in “digitally focused trials.” — NIHR Research (@NIHRresearch) June 30, 2022.

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Documentation Vaccines 52

FDA Law Blog: Biosimilars

JUNE 21, 2023

Background – Strategic Priority to Advance Health Equity In CDRH’s 2022-2025 Strategic Priorities , “Advance Health Equity” is listed as one of the three strategic priorities along with “Promote a Modern and Diverse Workforce” and “Enhance Organizational Agility and Resilience.” We previously blogged on the draft guidance here.

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Documentation Hospitals 45

Pharma in Brief

AUGUST 7, 2023

These amendments are scheduled to come into force no later than January 1, 2025. Link to consultation document: The consultation document can be found on CIPO’s website here. Background As we reported here and here , on June 22, 2023, Canada’s federal government amended the Patent Act to introduce PTA.

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Documentation 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. The draft guidance indicates that this timetable will be announced by September 30, 2025. There will be a transition period before requiring all De Novo requests to be submitted electronically.

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Documentation Labelling 52

Pharmaceutical Technology

JUNE 1, 2023

While extremely disappointing for Intercept and the NASH community, this vote is not entirely surprising, as the FDA had released briefing documents prior to the AdCom meeting, showing that the agency had concerns over potential risks of liver injury and diabetes from the drug, especially given its “modest” efficacy (8.6%

Diabetes 52

Diabetes Documentation 52

Express Pharma

AUGUST 2, 2023

By 2025, I believe one of the four healthcare providers including doctors will be using digital health actively, and patients’ needs will drive this change. While this means that we have achieved a high level of technical maturity, the care providers’ competence is not up to that level. How does the Summit address this reality?

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Hospitals Nursing Homes Documentation 98

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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Hospitals Inpatient Documentation Communication 94

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.

Vaccines 97

Vaccines Communication Immunity Immunization 97

European Pharmaceutical Review

FEBRUARY 1, 2023

With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. The CTR foresees a three-year transition period, from 2022 to 2025. Registration and the posting of results were also separate processes.

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Documentation 82

FDA Law Blog: Biosimilars

JULY 6, 2023

Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R. For example, during the transition period, FDA would need to address the effect of the new regulation to the existing inspection process and staff would need time for training to effectuate execution and enforcement.

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Documentation Labelling 52

Pharmaceutical Technology

MAY 11, 2023

Notably, the agency plans to focus on anti-cancer medicines this year as a “pathfinder to embed the lessons learned” from the pandemic, per the EMA’s final programming document that covers its plans until 2025.

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Documentation Vaccines 52

pharmaphorum

OCTOBER 18, 2021

8 It’s encouraging to see this as one of the goals in the EMA’s 2025 Regulatory Sciences Strategy. And advances in digitalisation could facilitate a move from document-based submissions to data-based submissions, through a cloud platform like the one being developed by Accumulus Synergy.

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Vaccines Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 140

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. If I’m a pharmacy operator, what do I actually need to do to make sure that I don’t get a fine in 2025 for failure to comply with DSCSA?

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Communication Pharmaceutical Manufacturing Documentation 105

STAT

MAY 1, 2023

Senators drafting reforms to the drug middlemen industry have delayed their effective date by at least 10 months, according to new documents obtained by STAT. The original date that pharmacy benefit manager reforms were supposed to take effect was Jan.

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Documentation Drug Pricing 241

PharmaShots

JUNE 1, 2023

PDC*line Pharma has developed a novel approach using an allogeneic plasmacytoid dendritic cell (PDC) line as an antigen-presentation platform showing great potency to prime and expand tumor-specific CD8+ T cells in vitro and in vivo in a humanized mouse model (data illustrated in Part III of this document).

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Immunity Immunization Vaccines Health and Personal Care Stores 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

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. Therefore, the NHC requests that CMS offer more clarity into exactly how it will exclude QALY-based metrics from analysis of certain evidence in value-based decisions.

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Drug Pricing Drug Development Documentation Communication 40