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But here’s the uncomfortable truth: The scientific community has not definitively determined the health effects of high seed oil consumption. Critics of seed oils are often accused of spreading fear or misinformation — and sometimes those concerns are justified. Read the rest…
To start, FDA officials wrote in an executive summary shared before the meeting, it’s hard to know when it qualifies as a device under the agency’s definitions. Why is it so hard to regulate generative AI products in medicine? Continue to STAT+ to read the full story…
The wastewater continued to contain high concentrations of organofluorines and other compounds that meet the definition of PFAS even after treatment. Oganofluorines — a group that includes per- and polyfluoroalkyl substances, or PFAS — were found in wastewater in eight large municipal treatment plants.
I wanted to create a shared definition of patient centricity here at Ardelyx, and then weave that into the fabric of the organization." I wanted to create a shared definition of patient centricity here at Ardelyx, and then weave that into the fabric of the organization,” she said.
The PLI scheme has definitely been a turning point for India’s pharma manufacturing, especially in APIs and KSMs. Global trade has definitely become more unpredictable, but we’re navigating it with a clear strategy.
FDA found that the defect classification system lacked clear definitions for “critical,” “major,” and “minor” defects. Visual inspection deficiencies and trending gaps (Warning Letter – January 2024) A large-volume parenteral (LVP) facility received multiple market complaints related to visible glass particles and black fibres.
As a third-year student pharmacist, I have figured out what works for meand what definitely does not work. A big part of the experience is building those memories of late-night (or early mornings- but I am definitely a night owl) study sessions with friends. Learning, for me, has become a process.
The updated definition for HRMM is increasingly important as there is an increased focus on how to improve outcomes for patients with HRMM, functional HRMM, and true extramedullary disease. International Myeloma Society/International Myeloma Working Group consensus recommendations on the definition of high-risk multiple myeloma.
So much smaller, much leaner and definitely more startup mentality. And we’re trying to get on the line with a pharmacy and they’re working on getting a license in a certain state, so understanding pharmacy law, my MPJE definitely came in handy. So there’s still definitely a lot of PharmD in there.
The final step focuses on ensuring consistency of data definitions across datasets, which is essential for producing a cohesive foundation built with data from multiple sources.
Sterility as a Critical Quality Attribute: Among all the Critical Quality Attributes (CQAs) of a sterile drug product, sterility is uniquely distinct both in its definition and in the approach required to ensure it.
Nonetheless, antimicrobials should always be modified based on results of culture and sensitive testing to definitive therapy agent(s) that have the narrowest spectrum possible. This article is written to meet this demand, acknowledging that it does not offer a complete picture of antimicrobial selection.
One issue with aspiration pneumonia is that aspiration is a very common event, occurring in up to half of the population yet “aspiration pneumonia” lacks a specific definition that separates it from other pneumonia diagnoses. Simply aspirating GI contents into the lungs does not result in bacterial pneumonia.
I can't use elranatamab in frontline today, but based on what we’ve seen, I’m definitely excited to see more data emerge. We're not going to have payer support to use these drugs frontline right now. But this data helps frame our point of reference for future decision-making. Hinojosa : OPC is my favorite meeting of the year.
Measles outbreak case definition. Travel Med Infect Dis. 2023;51:102494. doi:10.1016/j.tmaid.2022.102494 2022.102494 2. How to prevent norovirus. January 13, 2025. Accessed April 28, 2025. Travelers’ health. Accessed April 28, 2025. Texas Department of State Health Services. Updated April 10, 2025. Accessed April 28, 2025.
“There was definitely a perceived risk of changing the ways of working practices. Interestingly, quite a lot of respondents reported a gap in skills and knowledge of modern digital tools and what those technologies can bring to an organisation” Cross explains that the industry faces a complex web of challenges.
On the lithium, I definitely feel like me,” she says. She was put on the antipsychotic drug olanzapine and another mood stabiliser, lithium. She has now been taking lithium alone for a year, and it has been transformative. “On Continue reading.
Today, 45% of US counties meet the definition of a pharmacy desert. While mail-order and mobile delivery options can help, the most important step is understanding where these gaps exist and who they affect the most. That means large segments of the population must travel significant distances to access essential medications.
Glossary of key terms and definitions Sterility Assurance Level (SAL): The probability of a single unit being non-sterile after it has been subjected to a validated sterilisation or aseptic process. The world is watching. Patients are depending. The time for decisive, quality-led leadership is now.
Medication adherence is hard, so we haven't tracked medication adherence, but it is definitely something that for every patient we are looking at, we are trying to help them with. We're tracking pharmacist interventions to see what all the pharmacist is doing with each patient and looking at cost savings that go along with that.
These trials varied in their definitions of severe CAP, corticosteroids used, primary outcomes, and results. Investigators included patients with severe CAP based on the ATS/IDSA definition ( Table 2 ) and excluded those with previous use of steroids and vasopressor-dependent shock.
The trend is definitely upward, and post-pandemic awareness about nutraceuticals has accelerated this growth. The Indian nutraceutical market is set to grow sixfold by 2030 Kalka Prasad, AVP – Marketing, Crius Life, Crius Group The Indian nutraceutical market is projected to reach $64 billion by 2030.
When in doubt, always consult reliable sources for definitive information , such as UpToDate Lexidrug , Micromedex , Medscape , British National Formulary and others. This database is intended as a quick reference tool and should not replace the need for further research or professional clinical judgment.
11 The role of patient-centered evidence in the renegotiation process also requires greater definition. Although the statute references therapeutic benefit and unmet need, the draft guidance is silent on how CMS will gather and weigh patient-reported outcomes, registry data, or treatment experience narratives.
That is something we have definitely taken from transplant and shared with our other bispecific programs—especially now that we do bispecifics in solid tumors.
I’m coming at it from the perspective of understanding the science behind it… When you talk about manipulating genes, that definitely tends to put some people off,” she said. “I Trinkman noted the hesitancy some patients have shown toward gene therapies, emphasizing the need for greater education about how these therapies work.
The increased funding for Ayushman Bharat is a definite step towards moving closer to universal health coverage, and such coverage should include modern treatments such as TAVI/ TAVR involving valve implantation or replacement.
Furthermore, CMS should ensure EHB definitions remain clear, flexible, and responsive to state-level innovation, maintaining consistency and avoiding confusion among insurers and consumers. CMS should preserve existing protections that ensure affordable, accessible coverage for individuals with complex health care needs.
8 By these definitions, more patients experiencing homelessness were sheltered than unsheltered ( Table 3 ). 8 A patient with unsheltered homelessness is defined as an individual residing in a place not meant for human habitation (eg, public space, building not intended for residential use, car, cardboard box).
The Association of American Medical Colleges also opposes shifting to a rebate model , which could reduce reimbursement for hospitals that comprise a critical safety net for patients.
Rare disease trials, by definition, struggle with small patient pools scattered across the globe. Trials in chronic conditions such as Alzheimer’s disease and other CNS disorders face notorious recruitment challenges, often because patients are treated in rural community settings that are not equipped to run clinical trials.
Ultimately, while this analysis does provide support for clinicians who lean towards early vasopressor administration, more data will be required before a definitive, practice-changing recommendation can be made in favor of routine early norepinephrine administration.
Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. This gap in the market has created a "gold rush" for compounding pharmacies and new startups.
340B legislative updates: States opposing manufacturer restrictions Recent legislative proposals aim to redefine program parameters, such as expanding eligible patient definitions and revisiting covered entity eligibility criteria. Tell them theyre paying for it.
Torrent Pharmaceuticals, headquartered in Gujerat, India, has signed definitive agreements for the acquisition of a controlling stake in JB Chemicals and Pharmaceuticals (JB Pharma) from global investment firm KKR at an equity valuation of Rs256.89bn ($3bn) on a fully diluted basis. Credit: Sai Thaw Kyar/Shutterstock.
The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations. Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks.
Mateja Kramer, PhD , global head of innovation at Novartis, and Nicholas Schill, PhD , senior director of landscaping & platform definition at AbbVie, will present as part of the conference’s Pharma Company Spotlights.
For example, the Trump administration removes statutory definitions Biden included for algorithmic discrimination, automation bias, and equity. But in a new analysis , STAT’s Casey Ross and Brittany Trang unpack crucial differences, and how they might impact health care applications for the technology.
These limitations stem from both definitional exclusions and inconsistent implementation. CMS can accelerate access by: Expanding Blue Button 2.0 Expanding USCDI to include these elements would improve care quality, but CMS and ONC must manage scope by offering modular data element tiers to reduce implementation burden.
As evidence evolves, pharmacists can lead in translating research into practice—implementing screening, personalized dosing, and interprofessional coordination while awaiting definitive trial results. 1-4 REFERENCES 1. Jiang Y, Dang W, Sui L, et al. Associations Between Vitamin D and Core Symptoms in ASD: An umbrella review. 2024;16:59–91.
1,2 The primary end point was event-free survival (EFS), which was defined as the time from randomization to the first occurrence of disease progression precluding definitive surgery, local or distant disease progression or recurrence, or death due to any cause. The key secondary end point was overall survival (OS). months (95% CI: 37.9,
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