Pharmaceutical Technology

JULY 24, 2025

July 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Updates in the ICH E6 (R3) guidelines refine the ways clinical trials are designed and operated. To explore how Zelta can support your organization’s clinical data management needs, download the document below. Credit: via Shutterstock.

Communication

Drug Topics

JULY 8, 2025

TCSs are the first-line anti-inflammatory treatment and their effectiveness and safety have been well documented.” Accessed July 8, 2025. The next step consists of treatment with topical anti-inflammatory therapies. 2 To better understand the prominence of corticophobia, researchers evaluated HCPs’ management strategies for AD.

Vaccines

Drug Topics

JUNE 11, 2025

This led researchers to explore a specific region of the world in order to better document patients’ understanding of the disease. The prevalence of psoriasis in the Gulf countries is not well-documented; however, recent studies suggested that psoriasis affects 0.5%-5.3% Accessed June 11, 2025. Accessed June 11, 2025.

Immunization

Viseven

JUNE 18, 2025

Scientific communication : Drafting slide decks, scientific responses, medical information letters, and training content using generative models, ensuring scientific accuracy and compliance in messaging and content. Previously, many organizations, including healthcare companies and facilities, were merely testing the waters.

Labelling

Pharmaceutical Commerce

JULY 16, 2025

Maintain unwavering transparency with patients, unequivocally communicating the non-FDA approved status of compounded medications and all associated risks, securing explicit informed consent. Implement and meticulously document robust quality control and assurance processes internally. May 30, 2025. May 21, 2025.

Compounding

PQA

NOVEMBER 26, 2024

In documentation of the care provided, the MTP Categories Framework promotes consistent identification of MTPs found and the interventions taken to resolve MTPs within MTM services. It is clear to me that this rational approach is vital for practice standardization and documentation. Applications for 2025 are due December 13, 2024.

Patient Care

Pharmacy Times

JULY 9, 2025

Autism Spectrum Disorder (ASD) impacts social communication, behavior, and daily functioning. SHOW MORE Discover how vitamin D supplementation may reduce Autism Spectrum Disorder symptoms and improve overall functioning in children with ASD. 4 Despite promising findings, evidence remains mixed.

Compounding Pharmacies

Pharmaceutical Technology

JULY 2, 2025

July 2, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Logistics is crucial for successful cell and gene therapy treatments. In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. Credit: via Shutterstock. Sign up for our daily news round-up!

Packaging

Pharmaceutical Technology

JULY 16, 2025

Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Experts also identified poor tolerability of regimens and resulting uncertainty regarding proposed dose, as per a briefing document published on 15 July.

Documentation

Pharmaceutical Technology

JULY 15, 2025

Robert Barrie July 15, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Hong Kong-listed Sino already owns a 4.91% stake courtesy of an investment in November 2024. Credit: Na_Studio via Shutterstock. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

Packaging

Pharmaceutical Technology

JULY 18, 2025

Manasi Vaidya July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Credit: [H_Ko]/Shutterstock.com In 2024, 50% of the novel drugs approved by the FDA had an orphan drug designation. As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress.

FDA

Pharmaceutical Technology

JULY 18, 2025

Abigail Beaney July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep. The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July.

FDA

pharmaphorum

JULY 7, 2025

By 2025, healthcare data is projected to grow at an annual rate of 36% - outpacing industries like manufacturing, financial services, and media by as much as 11%. Recent analyses from RBC Capital Markets estimate that healthcare accounts for approximately 30% of global data production.

Pharmaceutical Companies

Pharmaceutical Technology

JUNE 17, 2025

Manasi Vaidya June 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook A panel at the 2025 BIO International Convention discuss the state of the European biotech funding ecosystem. But much larger, later-stage funds are emerging in Europe, which can fund companies further. Sign up for our daily news round-up!

Communication

PharmD Live

JULY 7, 2025

The landscape of CMS Transitional Care Management (TCM) billing and compliance updates for 2025 is at a pivotal juncture. This aligns with CMS’s push for greater transparency and accurate service documentation. Documentation: The Foundation of Compliance CMS now expects bulletproof documentation for every TCM claim.

Documentation

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.

Hospitals

Pharma Marketing Network

MAY 23, 2025

In 2025, artificial intelligence is helping pharmaceutical brands bridge the gap between regulatory precision and meaningful engagement. In 2025, AI is helping medical affairs teams streamline global content review by auto-tagging references, linking claims to citations, and maintaining audit trails.

FDA

The FDA Law Blog

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.

FDA

PharmD Live

MAY 13, 2025

In response, the Centers for Medicare & Medicaid Services (CMS) introduced Advanced Primary Care Management (APCM) in 2025, a next-generation care management model designed to elevate clinical practice, reduce fragmentation, and reward outcomes over encounters.

Documentation

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.

Specialty Pharmacies

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.

Community Pharmacies

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

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.

Documentation

ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. 22 June 2023. EMA/321483/2020. 3 July 2020.

FDA

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.

Hospitals

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. §

Labelling

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.

Vaccines

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Global Strategy on Digital Health 2020-2025.” Wireless medical devices.

Health and Personal Care Stores

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.

Community Pharmacies

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Global Strategy on Digital Health 2020-2025.” Wireless medical devices.

Health and Personal Care Stores

The FDA Law Blog

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.

FDA

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 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. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J. 22 March 2018.

Health and Personal Care Stores

PQA

SEPTEMBER 28, 2022

Food security challenges disproportionately impact underserved communities, including communities of color, people living in rural areas, people who are differently-abled, older adults, LGBTQI+ people, military families, and military veterans.

Documentation

The FDA Law Blog

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.

FDA

NF2 BioSolutions

MAY 19, 2025

The trial requires 16 participants and is still actively recruiting as of May 2025. How frequently did you need to visit the study site or communicate with the research team? Due to me being interested in research & wanting to learn more about it, Hannah kindly sent me the list of documents that were referenced in their protocols.

Communication

The FDA Law Blog

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

Documentation

PQA

MAY 8, 2025

This guest blog is one in a series by sponsors of the 2025 PQA Annual Meeting on bridging payers and pharmacies to drive better care and lower costs. Key Findings from the Outcomes Consumer Survey: High Trust in Pharmacists: Over 95% of consumers are comfortable receiving medication and vaccine-related communications from pharmacists.

Vaccines