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The PLI scheme has definitely been a turning point for India’s pharma manufacturing, especially in APIs and KSMs. We’ve emphasized a cautious, wait-and-watch approach during periods of uncertainty, while simultaneously facilitating communication between industry stakeholders and the government.
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. PDA TR 22, ISO 14644, ICH Q9, Q10) adequately supported by the relevant data set.
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.
Even well-intentioned policies can create access disparities if communication and operational support are lacking. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set.
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.
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. Warning Letter: A formal communication from the FDA indicating significant GMP violations that may lead to enforcement action.
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. Pharmacy Times : How does the team ensure smooth transitions from inpatient to outpatient transplant care, particularly regarding medication management?
Rather than imposing stringent reconciliation deadlines, CMS should instead focus on enhancing consumer education and outreach efforts, providing greater access to free tax-preparation assistance, and improving clear, timely communications to help eligible individuals maintain compliance and avoid unnecessary disenrollment.
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.
Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. Maintain unwavering transparency with patients, unequivocally communicating the non-FDA approved status of compounded medications and all associated risks, securing explicit informed consent.
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.
Health management and care navigation applications (apps) should provide a unified experience that allows users to track medications, manage appointments, communicate with care teams, and receive tailored health education. CMS can accelerate access by: Expanding Blue Button 2.0
Autism Spectrum Disorder (ASD) impacts social communication, behavior, and daily functioning. 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. 2024;16:59–91.
FDA deleted the requirement that SIUU be clinically relevant and left only the requirement that the information be scientifically sound (thank you FDA on behalf of industry, we are still getting used to the SASS standard from the CFL guidance and yet another evidentiary standard imposed on product communications was a bit much).
Aytu is committed to royalty payments based on net sales as stipulated in their definitive agreement, including a product transfer cost. Find out more Aytu issued an initial payment to Fabre-Kramer Pharmaceuticals upon closure and will make another payment on the first anniversary of Exxua’s market release.
In September 2024, Medera entered a definitive merger agreement with Keen Vision Acquisition Corporation. “By generating patient-specific 3D human heart models from a simple blood draw, we aim to uncover the biological mechanisms driving disease in each child — and ultimately tailor treatments that improve their chances of survival.”
. “Our patients receive the vast majority of their care in their own communities, where they have the social support critical to navigating their cancer journey,” Lloyd Ketchum, MD, a hematologist and oncologist and division chair of cancer services at Essentia, told Becker’s. That’s the definition of value.”
FDA provides definitions for the three datasets. The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Update practices and training of end users also need to be addressed. In such cases, performance testing may be conducted again.
The LDT Rule itself provides no operational guidance, but only a definition. This inability to consult external experts could make communicating with FDA on important topics of safety and effectiveness even more challenging. As those that have worked with FDA know, the Agency is not an expert on all disease states or technologies.
There are definitely policy impacts that can influence health care outcomes based on on where you live as well.” Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Sign up for our daily news round-up!
Robert Barrie June 30, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook While zoonotic origin is the most likely source of the virus, a report says a definitive conclusion is not possible. Credit: Dalibor Sevaljevic via Shutterstock. Give your business an edge with our leading industry insights.
Identify intelligent communication strategies in healthcare through social media mgathers Thu, 08/25/2022 - 11:34 Teaser Image White paper_Identify intelligent communication strategies in healthcare through social media.png Teaser Content Download this whitepaper to learn how to create a solid digital opinion leader engagement strategy.
From my perspective, the real generator of change is the sudden need to communicate,” according to Heath Morlok , Associate Director of Oncology Integrated Customer Management at Merck. Communicating the vast array of treatment options to oncologists requires a renewed focus on education and personalization, Morlok said.
Many definitions in the literature embody what this entails. Core attributes including empathy, integrity, appropriate communication, accountability, and a commitment to reflective practice 2, 3 , and lifelong learning are essential. Professionalism is a complex and multifaceted construct.
As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe.
The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Criteria for regulation. Criterion 2. Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g.
advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems”). l)(1) (e.g.,
510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .
” This is the third year, after similar projects in Thailand in fiscal year. ” This is the third year, after similar projects in Thailand in fiscal year.
It also claims that the voice analysis tool can help them “understand how they sound to others, helping improve their communication and relationships.”. The globally recognised definition of health includes mental and social well-being in addition to the physical,” he notes. billion takeover by Google – and will be sold at $99.99
With all the holiday cheer though, definitely comes stress. What will your holiday hours be and has this been communicated to your customers? The earlier you can prepare your community, the easier it will be for everyone to plan ahead. . Send out mass communication to your customers via text message.
OPDP engages in a fair amount of formal study related to various aspects of its mission to protect public health by ensuring that prescription drug promotion is truthful, balanced, and accurately communicated.
This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024. This means updating the definition of medical devices to ensure consistency across borders.”
The paradigm shift from in-office visits to mandatory shutdowns was almost instantaneous and reliance on tele-solutions and digital communications consequently shot up. While many HCPs are open to receive digital communications and sampling programmes, one group that is not ready is older HCPs.
It might also be noted that this year the four letters involved five different communications vehicles, two of which were Banner Ads (the subject matter of the most recent letter). But in 2018 there was some definitive output from Dr. Janet Woodcock, then head of the Center for Drug Evaluation and Research (CDER) which houses OPDP.
They definitely helped get the human story across. There are plenty of rare disease drugs that aren’t so lucky, though, and Sanders says that in order for other treatments to avoid metreleptin’s early reimbursement difficulties more communication between every stakeholder at every stage is vital.
Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. There are a number of drivers behind the need to rethink value evidence and value communication. Changes are afoot – what to look for.
Reviewing 2019’s key digital health stories last year I suggested that, while big strides continued to be made, any definitive ‘coming of age’ moment for the sector was unlikely. So, what were the standout changes for digital health, and digital pharma for that matter, in this most unusual of years?
Research preferences questionnaire To design respectful messaging that would be sent to patients, the POR team worked with the MUSC Biomedical Informatics Center (BMIC) to develop digital workflows that were efficient for researchers and also with enterprise communications. Epic is MUSC Health’s electronic health record.
In addition to accessible services, the NHC is also strongly advocates for more inclusive communication. Plain language for patients with cognitive, developmental, intellectual, or neurological disabilities should not only be an optional modification, but a mandatory standard across all communications.
The second quote was “pharmacies have diligently transitioned from apothecaries into problem solvers , educators , and communicators.” ” This resonates with me on the topic, as pharmacy preceptors should consider how they can employ AI to help their learners become better problem solvers, educators, and communicators.
Many definitions in the literature embody what this entails. Core attributes including empathy, integrity, appropriate communication, accountability, and a commitment to reflective practice 2, 3 , and lifelong learning are essential. Professionalism is a complex and multifaceted construct.
This article explores the definition and importance of multichannel marketing in pharma, as well as the emerging opportunities it presents. With segmentation and automation, emails can be tailored to specific audience segments, ensuring relevant and timely communication.
As this trend unfolds, it is vital to understand the benefits 5G brings, how it impacts healthcare communication , and how healthcare businesses can leverage it. 5G represents the 5th generation of cellular technology and is the gold standard in wireless communication today. In this article, we will explore these opportunities.
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