FDA Law Blog: Biosimilars

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

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

National Association of Boards of Pharmacy

OCTOBER 23, 2024

The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” For wholesalers, these exemptions are granted until August 27, 2025. What requirements are dispensers actually exempt from?

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Packaging Documentation Pharmacy Technician 49

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

Express Pharma

OCTOBER 6, 2024

Anurag Gokhale’s submission, focused on voice search-enabled systems for documentation efficiency, received the Golden Innovation Award. Key jurors included industry leaders from companies like Serum Institute, Cipla, and Aurobindo Pharma. The top 10 innovators received accolades for their groundbreaking ideas.

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Documentation 102

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

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 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Comments on the proposed order are due May 25, 2025. Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order.

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Express Pharma

MARCH 12, 2024

300 crore, over the next two fiscal years (150 units each in 2024-25 and 2025-26). We appeal to the Government to ensure NIPER imparts training for documentation because machines alone cannot cause compliance of Schedule M. Documentation is an altogether different skill without which compliance is not possible.

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Documentation Pharmaceutical Manufacturing 104

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country. If the applicant has been certified as a small business by FDA, the fee is $3,650.

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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

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

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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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

Flip the Pharmacy

SEPTEMBER 19, 2024

We shared our goals with him and encouraged him to check his blood pressure and document his readings so he can share with his provider to better guide treatment and prevent episodes of hypotension. Currently, we are expecting him in a couple days at the pharmacy and we will educate him on proper blood pressure technique for using his cuff.

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Pharmacy Technician Documentation 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

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

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 44

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

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 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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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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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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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.

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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.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Express Pharma

OCTOBER 19, 2024

The Union Budget 2024-2025 aims to prioritise employment and skilling, recognising its crucial role towards attaining its goal of Viksit Bharat. pdf [link] /sites/default/files/kps-document/Pharmaceuticals.pdf [link] 300a3c/uploads/2024/02/ 20240719952688509.pdf References [link] [link] 281%29.pdf

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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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Hospitals Inpatient Documentation Communication 98

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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Putting Patients First Blog

SEPTEMBER 9, 2024

CY 2025 PFS proposed rule). These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer. The NHC supports the increased utilization of Z-codes to document social risk factors as part of the PIN services.

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Insurance Coverage and Processing Documentation Vaccines Communication 40

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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Fuld & Company Blog

AUGUST 20, 2024

With rate reductions anticipated later in 2024 or early 2025, financial buyers, particularly private equity firms which are most impacted by interest rates, are currently cautious, and deal making has slowed as a result. Has private credit become a credible alternative for middle market firms?

Documentation 52

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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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

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

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

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

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