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Despite a high prevalence of childhood and youth-aged obesity, the use of medications for treating obesity is persistently low among children and young adults (YA), according to an abstract presented at the American Diabetes Association’s 85th Scientific Sessions, held in Chicago, Illinois, from June 20-23, 2025. Accessed June 25, 2025.
The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis. June 11, 2025. Accessed June 11, 2025. of patients who received placebo. News Release. Bristol Myers Squibb.
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.
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.
On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed products. By August 1, 2025: Complete confirmatory testing for at-risk products.
OctariusRx President and Consultant Pharmacist Victor Alves is presenting Pharmacy Documentation: Tips for Patient Safety and Survey Success at the ASCA 2025 Conference & Expo, April 30May 3, in Denver Colorado. He will discuss the essential elements of patient safety through complete pharmacy documentation.
By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.
Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.
In response to this, the Leeds Teaching Hospitals NHS Trust (LTHT) pharmacy team has recently launched its ‘Digital Induction’ document. Initial feedback has been overwhelmingly positive, leading to the creation of additional documents tailored for line managers and pharmacy students with specific digital needs.
This 2025 vendor landscape review highlights how PharmD Live stands out by combining pharmacist-led clinical expertise, AI-powered insights, and fully CMS-aligned virtual care services, delivering tangible, reportable results across complex patient populations. We show you the why and what to do about it before the patient deteriorates.
By 2025, over 71 million Americans (26% of the population) are expected to use RPM services, with the US market projected to double to $29+ billion by 2030. Operational Strain: The 2025 Medicare Physician Fee Schedule slashes reimbursement rates by 2.83%, intensifying the need for efficient, compliant RPM workflows to protect margins 3.
Speaking at the ASCA 2025 Conference & Expo, April 30May 3, in Denver Colorado was a great time. My presentation focused on safe medication management through complete pharmacy documentation. ASCA 2025 Conference & Expo The ASCA Conference & Expo is the premier event for the ASC community.
In 2025, healthcare leaders face a critical choice: selecting a CCM partner that not only meets CMS standards but also drives measurable patient outcomes, operational efficiency, and long-term value. Their workflow ensures seamless EHR integration, documentation, and audit readiness for providers.
1,2,3 The reflection paper is currently open for public consultation, inviting feedback from stakeholders across the pharmaceutical sector until 30 September 2025. EMA/CHMP/BMWP/60916/2025. Brussels: Council of the European Union; 2 June 2025. Document 9286/25. References European Medicines Agency. COM(2020) 761 final.
Effortless document copying with “Edit in eWizard” Our team ensured version accuracy for the localization copy with the MLR-approved content item. Content creators can now be 100% sure that they are working on an approved version of the document without worrying about creating duplicates and accidentally working on an old version.
The ultimate guide to 2025 healthcare and life sciences conferences Stay ahead of the latest developments and networking opportunities in the health and life sciences sector with Fulds 2025 Health & Life Sciences Conference Directory. Whats inside?
This guest blog is one in a series by sponsors of the 2025 PQA Annual Meeting on unlocking clinical revenue from within pharmacy workflow. While clinical services represent the future, the practical challenge of documenting these encounters threatens to impede progress. The business of pharmacy is at a critical juncture.
“Alcoholic beverages have been used to enhance the enjoyment of meals by many societies throughout human history,” read a part of the 1995 document (a note Nestle says was added last-minute by a federal official who believed in wine’s benefits).
This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition. billion in 2025, to a total of $88.2 The Biden administration on Wednesday proposed an annual rule that sets payment rates for hospitals.
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.
Thats the promise of data-driven marketing , a strategy thats rapidly transforming how pharmaceutical companies approach promotion, education, and engagement in 2025. But in 2025, it’s about personalization at scale. Data is no longer a byproduct of campaignsits the foundation.
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).
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.,
When Zepbound is covered, prior authorization is usually required, and the patient may need to meet clinical requirements such as a BMI of 30 or more or a BMI of 27 or more with a comorbid condition like hypertension or Type 2 diabetes, and documented weight management efforts like a low-calorie diet and increased physical activity.
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.
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.
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.”
Once the 351 Rite Aid pharmacies in Pennsylvania finally close in 2025, that will be over 600 pharmacies in Pennsylvania that closed in the last 2 years. Pharmacists can get trained credentials, get up to speed and enrolled to generate $20, $30, $50 a month per patient in managing their medications a little better and documenting it.
Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
1 Following the current trend, there has been a significant rise in the number of documents mentioning both artificial intelligence (AI) and rare diseases. For documents published in 2014 this number was just six; in 2024 it was 157 ( Figure 2 ). 1 Figure 1 : Documents by year. 1 Figure 1 : Documents by year.
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: .
Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing. Also, this aspect is crucial for interpretable results. References Geukes Foppen RJ, Gioia V, Zoccoli A, Velez CN. cited 2025Feb].
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.
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.
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!
Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).
23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. In Neumanns Pharmacy, LLC , 90 Fed.
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. Exchange health information electronically and follow up within 7 days.
New changes to Medicare in 2025 Medicare is a federal health insurance program developed for people 65 and older and younger individuals with certain disabilities. This extra documentation can help the insurer decide if Rinvoq is medically necessary. This continues until your total drug costs reach $2,000 in 2025.
However, Mounjaro isnt listed on the 2025 Medicare Part D Formulary for Kaiser , so you may have to call your plan administrator for verification. Like other similar GLP-1 agonists, Mounjaro is approved to treat diabetes and is typically covered by most Medicaid plans for this purpose.
This means the Aetna plan will only cover Mounjaro if the patient’s medical provider provides documented proof that the person meets certain requirements, such as a diabetes diagnosis or concerning blood glucose levels. Formulary categorization: Each Aetna insurance plan has its own drug formulary, or list of covered drugs.
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.
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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