Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019. This compares to 114 that were issued during 2019.

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pharmaphorum

DECEMBER 19, 2022

A Member of the European Parliament since 2019, she stated that what happens in a crisis is that existing inequalities get exaggerated. There were communication and psychology problems, he explained, and documentation was scarce or missing. Fitzgerald opened the discussion.

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FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

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European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. 25 In 2021 an estimated 25 million children under the age of one year did not receive basic vaccines, and the number of completely unvaccinated children increased by five million since 2019. 2019; 9:11409.

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pharmaphorum

JANUARY 27, 2023

She knows only too well how understanding the importance of patient centricity is crucial to the success of any modern life sciences company – but how has the landscape changed since 2019? “I Having the ability of these groups to be able to communicate directly with patients is tremendous.”

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National Association of Boards of Pharmacy

JULY 22, 2022

Many pharmacists can now administer diagnostic tests and vaccines, as well as dispense treatments for coronavirus disease 2019 (COVID-19). Telehealth capabilities were also expanded, allowing patients in rural or underserved communities to access pharmacist care. Updates will be posted on the NABP website and other communications.

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Syner-G

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

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Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. Clarity in communication is not just about convenience; it is a fundamental aspect of ethical medical practice and research.

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pharmaphorum

OCTOBER 4, 2022

The final guidance follows the draft CDS software guidance issued on the same date in 2019. Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g.

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The Happy PharmD

SEPTEMBER 15, 2024

Based on the data, the average distress level among pharmacists has decreased compared to previous reports spanning from 2019 to 2022. in 2019 to 2.59. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. It has declined from 3.25

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Proxsys Rx

AUGUST 28, 2024

Establishing communication lines between internal and external 340B teams ProxsysRx’s 340B team leaders conduct twice-weekly calls with the team leaders of the health systems whose 340B programs they’re managing. Worse still, none of those silos are designed to enable easy communication with one another.

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors. For DCTs, even a small virtual component can make the trial somewhat decentralised.

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Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). Translational Medicine Communications, 4(18). Comparison of research spending on new drug approvals by the National Institutes of Health vs the pharmaceutical industry, 2010-2019. [link] 2 Aiyegbusi, O., Macpherson, K., Washington, J., Newsome, P., and Calvert, M. link] 3 Cummings, J.,

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Proxsys Rx

JULY 10, 2024

A 340B hospital’s patient information is likely to be in one place, while its insurance information is in another place, and its 340B pharmacy data is in still another place — and none of those data sets (or the people who manage them) are set-up to communicate easily and seamlessly with one another.

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Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program. Blendon, R., and Schnieder, E. Casalino, L.,

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Viseven

DECEMBER 13, 2024

RPA employs software robots, or bots, to carry out tasks such as data entry and extraction, insurance claims processing, insurance verification, payroll calculations, document verification, employee onboarding, and many others. According to McKinsley, 55% of patients are more satisfied with virtual visits than face-to-face appointments.

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Putting Patients First Blog

JULY 15, 2024

Engaging these communities in the policy development process ensures that their voices are heard and that their unique perspectives are incorporated into policy decisions. This includes obtaining informed consent, anonymizing data, and clearly communicating how the data will be used and protected.

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Putting Patients First Blog

JANUARY 10, 2024

Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.

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Putting Patients First Blog

NOVEMBER 14, 2023

A 2019 study highlighted that physicians’ biases could influence their clinical decision-making, which underscores the importance of awareness and training to mitigate such biases.15 15 The NHC advocates for rigorous, transparent documentation of the medical rationale in such instances to prevent discriminatory practices.

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Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Sincerely, Randall L. Retrieved from [link] Comments.pdf 5 Sirugo, G.,

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RX Note

FEBRUARY 23, 2023

Teaching - A selfless effort driven by passion Ideation - Dream big, start small Perspectives - How we viewed the world Work is Work - Do not take things too personal Knowledge is Not Free - The sad truth Communication - Food for thought Phone Addiction - Reflection on living Forget - Why I create notes?

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The Thyroid Pharmacist

JUNE 14, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! May 22, 2019. May 16, 2019.

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Putting Patients First Blog

SEPTEMBER 9, 2024

The continuation of audio-only communication options remains essential. These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer. County health rankings: Relationships between determinant factors and health outcomes. 3 Wiliams, D.,

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Putting Patients First Blog

SEPTEMBER 9, 2024

amazonaws.com/s3fs-public/documents/Update_HHS_Disparities_Dept-FY2020.pdf Retrieved from https ://www.cms.gov/files/document/quality-motion-cms-national-quality- strategy.pdf 8 James, C., Implementation Science Communications, 11(1) , 165. Structural racism and health inequities in the USA: Evidence and interventions.

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Pharmaceutical Technology

MARCH 30, 2023

One route to more engaged patients is clear, accessible information – but clinical trial documentation is often highly technical and full of jargon. Plain language summaries simplify clinical trial documentation, using language that any non-expert could understand. So why are so many clinical trials falling short of enrolment targets?

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The Thyroid Pharmacist

JANUARY 20, 2023

The first case is outlined in a 2019 report by Roberto Vita and his research team, and published in Revista da Associação Médica Brasileira. Markomanolaki and published in a 2019 issue of Journal of Molecular Biochemistry. Published 2019 Jul 22. Published 2019 Dec 9. Published 2019 Aug 15. vs. 398 U/mL). [1]

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Pharmaceutical Technology

JUNE 20, 2023

GlobalData forecasts that the market for AI platforms for the entire healthcare industry will reach $4.3bn by 2024, up from $1.5bn in 2019 [i]. Consent documents often describe technical medical conditions and regulatory bodies are increasing pressure on sponsors to ensure that patient-facing information can be easily understood by patients.

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Pharmaceutical Technology

JUNE 8, 2023

The onset of the Covid-19 pandemic was one catalyst; GlobalData social media analytics suggest supply chains received 1,908 mentions in 2019, compared with 25,636 in 2021. Supply chains are increasingly in the spotlight. Controlant’s validation of a science-based target demonstrates a clear commitment towards sustainability leadership.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2019;10:864.

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