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 104

European Pharmaceutical Review

AUGUST 1, 2022

The joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published a third workplan, setting actions to be delivered by 2025. According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products.

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Documentation 105

The FDA Law Blog

SEPTEMBER 11, 2024

We note that the other FDA guidance document on nitrosamines addresses NDSRIs. The revisions due in 2025 include testing for NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5 micrograms per day “for any unstudied chemical that poses a negligible risk of carcinogenicity or other toxic effects.”

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European Pharmaceutical Review

NOVEMBER 23, 2022

Prepare guidance documents related to innovative quality and manufacturing technologies . The QIG will work in line with the priorities emphasised in EMA’s Regulatory Science Strategy to 2025 , in which the regulatory body identified key goals and core recommendations for human medicines. The five key goals of this strategy are: .

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Documentation 111

The Checkup by Singlecare

MARCH 10, 2025

Certain insurance plans (such as ones from Blue Cross Blue Shield and United Healthcare ) may cover Ozempic but require prior authorization for coverage, meaning the prescriber needs to provide information such as blood tests or documentation to prove a treatment is medically necessary. How much is semaglutide without insurance?

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Compounding Insurance Insurance Coverage FDA 52

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 105

PQA

SEPTEMBER 30, 2024

As we continue progress towards completion of our strategic plan, Blueprint PQA 2025, our team has been hard at work alongside our valued members to deliver meaningful improvements and drive positive change in quality medication use. Today, we published the 2024 PQA Annual Report, which documents our progress towards our strategic goals.

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The FDA Law Blog

DECEMBER 12, 2024

Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Prehearing Ruling (Dec. 4, 2024), at 1.

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Controlled Substances Documentation 52

pharmaphorum

FEBRUARY 9, 2022

The main bullet points in the plan include an objective of eliminating any delays to procedures of 18 months or more by April 2023 and over 65 weeks by March 2024, and reducing all waits to less than a year by 2025 – a year after the next scheduled general election. end waits over a year for 99% of people by 2024, and everyone by 2025.

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Hospitals Documentation Insurance 52

PQA

DECEMBER 1, 2023

PQA’s strategic plan, Blueprint PQA 2025, includes the vision of achieving organizational excellence through structure and processes that deliver exceptional value to our members and stakeholders. If community pharmacists can easily collect these data, they can be an effective resource to promote clinical trial diversity.

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Community Pharmacies Documentation Communication 59

PQA

MARCH 28, 2025

As a first step, the PQA Blueprint 2025 was leveraged to shape efforts, and objectives, strategies, and tactics were developed to strategically support success of the MTM initiative. 1-2 years) Increase standardized HIT for documentation of MTM services Re-establish consensus on standards for clinical documentation for MTM services (e.g.,

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PQA

NOVEMBER 14, 2024

Cost highlighted progress towards completion of PQA’s strategic plan, Blueprint PQA 2025. The 2024 PQA Annual Report documents our progress towards the plan’s goals. “Goal two of our strategic plan is to advance the quality of pharmacist-provided care and services that optimize medication use, adherence and safety.

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Specialty Pharmacies Documentation Patient Care Immunization 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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Documentation 52

The FDA Law Blog

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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Labelling FDA Communication Documentation 64

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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European Pharmaceutical Review

JUNE 12, 2024

Future prospects Anticipating a positive Phase III outcome and a potential commercial launch in 2025, we aim to capture a substantial share of the market for primary and recurrent CDI patients, marking a turning point in the management of this condition. References van Prehn J, Reigadas E, Vogelzang EH, et al.

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PQA

SEPTEMBER 25, 2023

We continue to play a central role in driving meaningful improvements and positive changes related to medication safety, adherence and appropriate use.The 2023 PQA Annual Report documents our progress towards Blueprint PQA 2025. There are still numerous opportunities to be involved with PQA and impact quality medication use in 2023.

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Specialty Pharmacies Documentation Patient Care Immunization 52

Blog: Ask a Student Pharmacist

FEBRUARY 5, 2025

Bachelor of Science in MLS ceele001 Wed, 02/05/2025 - 16:27 BS in MLS The BS in MLS is the degree plan for students who are earning their first (or second) bachelor's degree, and who are seeking to become eligible to sit for the Board of Certification (BOC) exam.

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Documentation 52

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

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

Blog: Ask a Student Pharmacist

FEBRUARY 5, 2025

Bachelor of Science in MLS ceele001 Wed, 02/05/2025 - 16:27 BS in MLS The BS in MLS is the degree plan for students who are earning their first (or second) bachelor's degree, and who are seeking to become eligible to sit for the Board of Certification (BOC) exam.

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Documentation 52

DiversifyRx

MAY 24, 2024

Proper documentation of each encounter is key to determining what you can bill for. We will be devoting a significant portion of our Pharmacy Profit Summit 2025 to practical and effective medical billing. If this is an area you want to implement, there is no better place than PPS 2025. Medical billing can be confusing.

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Independent Pharmacies Documentation Insurance 59

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.

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Documentation Compounding Communication FDA 52

PQA

OCTOBER 22, 2024

Strengthen requirements for the use of standardized health information technology for documentation of MTM services. Sophie Nguyen, a Class of 2025 Doctor of Pharmacy student from The University of Illinois at Chicago, is a PQA APPE Rotation Student. Amplify the patient voice to improve the patient-centeredness of MTM programs.

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Process Improvement Documentation 52

Hospital Pharmacy Europe

JANUARY 6, 2025

The Oral Cancer Therapy Initiative provides community and hospital pharmacists with essential information about cancer drugs, side effects and adherence, while patients are given tools to document their experiences and facilitate better communication with the healthcare professionals they come into contact with throughout the system.

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Community Pharmacies Vaccines Hospitals Documentation 98

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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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

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

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.

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Documentation 52

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

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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Hospital Pharmacy Europe

NOVEMBER 27, 2024

When changes to pharmacist training and the need for DPPs were announced, Mr Kennett said there was ‘almost a fear or anxiety’ among pharmacists about becoming DPPs, as well as ‘a pressure down the road to deliver this’ in time for 2025/26.

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Documentation Communication Patient Care Hospitals 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

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 Documentation Dosage Communication 52

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

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Health and Personal Care Stores Vaccines Packaging Documentation 52

Viseven

JULY 16, 2024

According to the Deloitte report , the volume of health data rose by 40% between 2010 and 2020 and is predicted to climb even higher by 23% by 2025. Pharma companies deal with enormous amounts of health data. Yet an overwhelming 97% of data generated by healthcare facilities stays unused.

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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