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Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Whether it’s the hold time between filtration and filling, the location of EM plates, the frequency of visual inspection, or the number of media fill runs – decisions must be supported by documented rationale based on QRM (Quality Risk Management) princip
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Chinese researchers have developed a new method that significantly improves the efficiency and sustainability of beta-blocker (β-blocker) production. Notably, the team achieved rapid, continuous-flow synthesis of propranolol. According to their findings, the innovative amine-functionalised graphene oxide (NGO) membrane reactor enabled nearly 100 percent conversion and selectivity in under 4.63 seconds at 23 °C.
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Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.
Strengthen scientific justification and design defensibility FDA inspections increasingly focus on the “why” behind the “what.” Facilities must be able to explain and defend their design decisions – from air change rates and sampling locations to gowning protocols and torque limits based on science, data, and risk. Archive design basis documents for all facility, process, and utility decisions.
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The Pharmacist sits down with newly elected vice chair of the National Pharmacy Association and independent pharmacy contractor Sukhi Basra about what she hopes to achieve in her new leadership role and the support she believes the sector requires to ensure a more stable and clinically focused future. It was five minutes before the midnight […] The post Interview: New NPA vice chair on achieving ‘advocacy and a real voice’ for pharmacy appeared first on The Pharmacist.
The Pharmacist sits down with newly elected vice chair of the National Pharmacy Association and independent pharmacy contractor Sukhi Basra about what she hopes to achieve in her new leadership role and the support she believes the sector requires to ensure a more stable and clinically focused future. It was five minutes before the midnight […] The post Interview: New NPA vice chair on achieving ‘advocacy and a real voice’ for pharmacy appeared first on The Pharmacist.
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The NHS is under extraordinary pressure. Trying to book a GP appointment can often feel like an impossible task. Emergency departments across the country are bursting at the seams. Patients face long waits and overwhelmed services, and healthcare professionals are burning out. It’s clear the system is stretched far beyond its limits. But there is hope.
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A new analysis from ADVI shows how the federal government routinely neglected to provide oversight of the 340B program. While 99.7% of 340B providers escape scrutiny due to a lack of oversight, the majority of audits that are conducted reveal adverse findings, raising serious concerns.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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The new system meets the increasing demand for faster, more precise processes that enhance quality while boosting efficiency in the pharma manufacturing industry.
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Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.
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Most in a small group of patients receiving a stem cell-based infusion no longer needed insulin, but the drug may not suit those with more manageable type 1 diabetes.
Oncology pharmacists are increasingly shaping patient care by integrating remote care, medication reconciliation, and artificial intelligence (AI), as well as by addressing drug shortages.
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Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.
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By embracing innovation, maintaining a human touch, and leveraging expert partnerships, pharmaceutical companies can achieve compliance excellence - without breaking the bank.
The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.
Panelists discuss how collaboration between pharmacists and health care providers is essential for optimizing treatment outcomes in chronic graft-vs-host disease (cGVHD), emphasizing the importance of education, symptom management, and a multidisciplinary approach to ensure comprehensive, patient-tailored care.
Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.
In a study published in the journal Nature Machine Intelligence, Sheffield computer scientists in collaboration with AstraZeneca and the University of Southampton have developed a new machine learning framework that has shown the potential to be more accurate at inverse protein folding than existing state-of-the-art methods.
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A dramatic pullback in public biotech investment catalyzed by economic and regulatory upheaval is putting even more stress on startups navigating a yearslong downturn.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
CSL Behring has announced that the first patient in the UK has received HEMGENIX (etranacogene dezaparvovec) through the NHS, marking a significant milestone in haemophilia B treatment and NHS access to gene therapies. The treatment was administered at Guy’s and St Thomas’ NHS Foundation Trust in London to a patient from the North East of […] The post First UK patient treated with CSL Behring’s gene therapy for Haemophilia B appeared first on Pharmafile.
A cancer charity has urged patients to consult with medical professionals – including pharmacists - before taking any weight loss medication. Cancer charity Macmillan Cancer Support says it has received ‘a flurry of calls about the medications’ asking whether they are safe to take with cancer treatments and questions around accessing them. It comes amid […] The post Cancer patients urged to consult with pharmacists before taking weight loss drugs appeared first on The Pharmacist.
Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
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