FDA Law Blog: Biosimilars

JUNE 10, 2024

Below we highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. Communication Best Practices During a BIMO Inspection Provide timely and accurate responses to information requests.

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Communication Documentation 111

pharmaphorum

FEBRUARY 28, 2022

The government previously announced £150 million (around $200 million) to help drive digitisation in social care, and a target of 80% of social care providers to have digital social care records by March 2024.

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Documentation Communication 115

Board Vitals - Pharmacist

DECEMBER 1, 2023

With 2024 rapidly approaching, there comes the question of New Year’s Resolutions. Patient Communication Some call it creating “happy patients,” others want to improve “patient experience,” and yet others mention “patient satisfaction.” To simplify our EHR and make documentation easier and quicker.

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Communication Documentation Diabetes 98

European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. This may cover anything from waste management, decontamination and health and safety issues to project controls including scheduling, resource tracking and communications.

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Pharmaceutical Manufacturing Packaging Documentation Communication 59

Proxsys Rx

APRIL 1, 2025

In a nutshell, says ProxsysRx 340B Optimization Manager Chance Spivey, the CE would have to pay retail prices first to allow for replenishment and THEN submit documentation like they do for 340B ESP (this time with even more claims info). Automate your 340B program with customized software streamlining documentation and reporting.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Documentation Drug Pricing 52

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

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Documentation Labelling Communication 105

Pulses

SEPTEMBER 26, 2023

This shift highlights the significance of effective communication, teamwork, and adaptability. Despite the challenge of quantifying these skills, their influence on a student’s ability to cultivate professional relationships, effectively communicate, and collaborate in a team cannot be overstated. teacher), entertainment (ex.

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Communication Hospitals Documentation 59

Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. These steps can significantly reduce errors, improve overall compliance, and ensure responsible stewardship of public funds.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Documentation Hospitals Communication 52

ID Stewardship

DECEMBER 13, 2024

BCPS, BCIDP Article posted 13 December 2024 If you cannot measure it, you cannot determine if you have changedit. Along this line of thought, I have also learned to be gentle with how I communicate my lack of confidence in data that is shared with me. Authored by: Timothy P. Gauthier, Pharm.D.,

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Communication Medical Records Inpatient Documentation 90

Putting Patients First Blog

APRIL 8, 2025

Sponsors must also communicate how patient data are collected, processed, and used throughout the AI lifecycle, ensuring transparency and maintaining public confidence. 56 ,57 ,58 Finally, comprehensive documentation is essential for reproducibility and public confidence. Strong privacy protections are also essential.

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Documentation Labelling Communication 52

Putting Patients First Blog

FEBRUARY 5, 2024

A Reminder of NHC Benefits February 5, 2024 By: Bob Scott, Director, Member Services The National Health Council (NHC) brings diverse organizations together to forge consensus, drive patient-centered health policy, and provide a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers.

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Documentation Communication 59

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

Pharmaceutical Technology

JUNE 17, 2025

Having a long-term partner, who can help build an ecosystem for the long term help, and this has been well documented in the US, he added. He cited the example of VIB’s work with Belgian biotech argenx to develop an asthma treatment, ARGX-118, which argenx will now further develop. Sign up for our daily news round-up!

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National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. So, what does this all mean for DSCSA implementation for the dispenser community?

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Pharmacy Technician Documentation Communication Packaging 45

Putting Patients First Blog

JANUARY 22, 2024

January 22, 2024 By: Annlouise Assaf – Sr. However, content must be presented in a clear and easily accessible way using plain language that is easy to understand and effectively communicated. There are customizable health literacy checks content developers can include when reviewing their documents. Patient Educ Couns.

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FDA Law Blog: Biosimilars

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Draft Guidance Finally, as part of MDUFA V , FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024.

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Documentation Communication 45

ID Stewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the June 2024 IDstewardship Newsletter Tip 1: Start by picking an article type and journal The article type (e.g., brief report, concise communication) will provide structure guidance (number of words, figures/tables, references allowed). Gauthier, Pharm.D.,

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Documentation Communication 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics. Please check your email to download the Report.

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Documentation Hospitals Dosage Drug Pricing 97

Putting Patients First Blog

OCTOBER 3, 2024

Consensus Framework Makes International Debut October 3, 2024 By: Joy D. Third, it promotes appropriate transparency and accountability in our individual and collaborative efforts, encouraging open communication to enhance accountability and reduce conflicts of interest. Consensus Framework document here. health system.

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Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. The NHC supports the development and use of processes and tools that enhance beneficiary experience, making interactions with the MPPP smoother and more intuitive for all beneficiaries.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. The NHC supports the development and use of processes and tools that enhance beneficiary experience, making interactions with the MPPP smoother and more intuitive for all beneficiaries.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

SEPTEMBER 3, 2024

Furthermore, it is crucial to understand how patients perceive the communication and support they receive from health care providers regarding the management of their medications. Additionally, the NHC recommends including questions that explore how these access challenges were communicated and managed by health care providers.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

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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Medical Records Documentation Communication Dosage 52

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.

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

GMPSOP

MARCH 20, 2024

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount? Additional documents included each month. Subscribe f.

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Documentation Pharmaceutical Manufacturing Labelling Communication 52

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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Health and Personal Care Stores Insurance Coverage and Processing Communication Documentation 52

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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Insurance Coverage and Processing Communication Documentation Diabetes 40

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

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Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

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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Documentation Communication Mayo Clinic Drug Development 52

The Happy PharmD

SEPTEMBER 15, 2024

The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. A cultural shift within the profession is also needed, encouraging open communication and prioritizing self-care to create a supportive environment for pharmacists.

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Insurance Coverage and Processing Dosage Documentation Communication 52

European Pharmaceutical Review

APRIL 14, 2025

In the UK, the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 1 have passed through the UK legislative procedure and will apply from 23 July 2025. Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer.

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Hospitals Documentation Packaging Communication 52

Big Molecule Watch

JUNE 4, 2024

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program.

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Documentation Communication Biosimilars 53

ID Stewardship

APRIL 13, 2023

An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

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Hospitals Inpatient Documentation Communication 98

Putting Patients First Blog

SEPTEMBER 26, 2024

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials (PDF) September 26, 2024 The Honorable Robert M. As part of this ongoing commitment, the NHC convened a virtual meeting on August 5, 2024, to discuss this draft guidance. Califf, MD Commissioner U.S.

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Communication Clinical Pharmacology Documentation Drug Development 52

Putting Patients First Blog

FEBRUARY 6, 2024

Nature Communications, 11(6265). Translational Medicine Communications, 4(18). autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., link] 2 Aiyegbusi, O., Macpherson, K., Washington, J., Newsome, P., and Calvert, M. link] 3 Cummings, J.,

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FDA Law Blog: Biosimilars

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. Some unanswered questions remain.

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Drug Development Communication Documentation Labelling 59

Putting Patients First Blog

SEPTEMBER 9, 2024

We appreciate CMS’ efforts to gather public input before finalizing the 73 new HCPCS codes made effective on April 1, 2024, and the 127 new codes made effective on July 1, 2024. amazonaws.com/s3fs-public/documents/Update_HHS_Disparities_Dept-FY2020.pdf Implementation Science Communications, 11(1) , 165. Auerbach, J.,

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Insurance Coverage and Processing Hospitals Inpatient Documentation 40