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 Insurance Hospitals 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.

Documentation 52

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

IDStewardship

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 Documentation Communication Patient Care 236

ISPE

NOVEMBER 2, 2022

Strategic plan refresh for 2023–2025 involved an adaptation from the existing strategic plan, with the Society taking a “very confident position: Shaping the Future of Pharma and bringing quality medicines to patients worldwide.”. Expenses for documents and conferences have been higher this year.

Documentation 52

Documentation Compounding Communication FDA 52

PQA

JANUARY 24, 2024

While my role tends to be more behind the scenes than that of some of my colleagues, the goals and objectives of our stakeholders as mapped out in our Blueprint 2025 remain top of mind for me every day as I think about our business processes, finances, human capital, technology, and operations.

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Documentation 40

The FDA Law Blog

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 FDA Patient Care Hospitals 45

The FDA Law Blog

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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FDA Documentation Labelling 52

The FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). As a result, there generally will be no incentive to fortify foods with certain beneficial nutrients.

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FDA Labelling Packaging Documentation 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%

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FDA Documentation 52

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.

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Vaccines Communication Immunization Documentation 102

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 87

The FDA Law Blog

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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FDA 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

PQA

SEPTEMBER 28, 2022

As part of PQA’s commitment to health equity – and outlined in our Blueprint PQA 2025 strategic plan – we are committed to advancing best practices, through research and education, on patients’ unmet social needs and barriers to equitable medication access, safety and appropriate use.

Documentation 52

Documentation Communication 52

ISPE

MAY 8, 2023

An ISPE 2023–2025 Strategic Plan objective—foster partnerships and collaboration that advance ISPE’s mission—is addressing this need through partnerships with the ISPE Foundation and industry supporters.

Documentation 52

Documentation 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 Pharmaceutical Companies Pharmaceutical Companies Documentation 139

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

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FDA Documentation Labelling 59

ISPE

OCTOBER 27, 2022

Covered by Medical Device Regulations according to decision tree per Medical Device Coordination Group (MDCG) Guidance 2019-11: Covered by Medical Device Regulations according to decision tree per MDCG document 2019-11: 1. Global Strategy on Digital Health 2020-2025.” 37 Med-Tech News. Published 21 March 2022. Published 18 August 2021.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Covered by Medical Device Regulations according to decision tree per Medical Device Coordination Group (MDCG) Guidance 2019-11: Covered by Medical Device Regulations according to decision tree per MDCG document 2019-11: 1. Global Strategy on Digital Health 2020-2025.” 37 Med-Tech News. Published 21 March 2022. Published 18 August 2021.

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Health and Personal Care Stores FDA HIPAA Communication 52

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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Immunization Vaccines Health and Personal Care Stores Labelling 40

ISPE

SEPTEMBER 11, 2023

Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. EMA Regulatory Science to 2025: Strategic Reflection.” EMA/CHMP/BWP/187162/2018. 22 March 2018. www.ema.europa.eu/en/documents/report/meeting-report-joint-biologics-working-party/quality-working-party-workshop-stakeholders-relation-prior-knowledge-its-use-regulatory-applications_en.pdf

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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 96

ISPE

SEPTEMBER 8, 2023

The EU The national competent authorities of the 27 EU member states, plus those of Iceland, Liechtenstein, and Norway, and the European Medicines Agency (EMA) released the “European Medicines Agencies Network Strategy to 2025” in 2020 10. CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.” 22 June 2023.

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FDA Dosage Documentation Communication 52

The FDA Law Blog

NOVEMBER 8, 2022

She indicated the requirements went out for comments and expects the group to finalize the document by early next year. He also shared that the three 2022 – 2025 priorities are: Promote a modern and diverse workforce, Enhance organizational agility and resilience, and. Advance health equity. Covid-19 Impact.

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FDA Documentation Patient Care Hospitals 59