FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Express Pharma

JANUARY 10, 2025

This requires clear communication with data principals about personal data usage and consent processes.” While the Act provides certain exemptions for research, these activities must adhere to specific standards to ensure lawful and secure data processing with purpose limitation.

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Express Pharma

JANUARY 3, 2025

Data integrity and documentation: The need for accurate and reliable data is paramount. Regulatory bodies require strict documentation and data tracking without any discrepancies. However, communication barriers, and conflicting priorities can hinder collaboration efforts.

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Pharmafile

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. read more

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pharmaphorum

JUNE 22, 2021

The UK’s Department of Health and Social Care has published a document setting out its strategy on handling patient data – and defending its plan to transfer millions of GP records into a centralised database. The post UK gov’t defends NHS data sharing plans in strategy document appeared first on.

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National Association of Boards of Pharmacy

MAY 28, 2025

This includes an online renewal application where pharmacies provide supporting documents confirming compliance with the accreditation standards. Home Infusion Therapy Pharmacy Accreditation Process Pharmacies undertake a thorough evaluation process to earn NABPs Home Infusion Therapy Pharmacy Accreditation.

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Putting Patients First Blog

JULY 1, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

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GMPSOP

OCTOBER 16, 2022

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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Syner-G

SEPTEMBER 20, 2023

Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.

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Viseven

JULY 10, 2024

It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication. As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences.

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Express Pharma

APRIL 30, 2025

It facilitates efficient planning, communication, and project execution between pharmaceutical companies and their CDMO. Thus, project leaders must enforce consistent and coherent communication channels to ensure alignment on project goals, timelines, and expectations as well as sharing of data using secure platforms.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.

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pharmaphorum

MAY 25, 2022

“Where it is impossible to restrict access to HCPs, due to the congress platform or equivalent, there must be a clear statement to the attendee that the materials/communication are designed and intended for HCPs only.”. Here, we take a look at the top five takeaways from the document: 1. The codes still apply. End of the host country.

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European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

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pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. ” To help communicate the new guidance, the PMCPA is planning to run two webinars next month for companies and media organisations, on 9 February and 21 February.

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Express Pharma

AUGUST 23, 2023

Specifically, during the Delta wave, vaccination was 68 per cent effective at preventing infection in residents without a documented exposure but was just 26 per cent effective in residents with exposure to an infected cellmate, the researchers said.

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Eye on FDA

AUGUST 10, 2023

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. And the increase in profile of Spanish releases would also be higher when there are fewer press releases if the number of bilingual communications remained the same. Overall, there have been shifts in the way the agency is communicating.

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RX Note

JUNE 11, 2025

Patient-Centred Approach In addition to the 5 fundamental steps, a patient-centred approach to decision-making is essential.

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PharmaState Academy

MARCH 6, 2024

CASE STUDY Enhancing Interpersonal Skills Effective Communication with Multidisciplinary Healthcare Teams Table of Contents Case Study Context and Background: In the dynamic landscape of pharmaceutical sales, effective communication with multidisciplinary healthcare teams is paramount. Their task?

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Eye on FDA

NOVEMBER 17, 2020

Vaccination for COVID-19 not only requires business planning, but communications planning in support of the decisions. Related to both of these first two questions – what sort of documentation will be necessary for an individual – either employee or customer – to present evidence of inoculation?

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Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The EMA set up a task force in 2016 in light of issues concerning medicine availability and supply chain.

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pharmaphorum

FEBRUARY 4, 2021

There needs to be widespread information available to the general public, training for professionals and patients and targeted communications to health and political institutions. Giuseppe Recchia, director of Tendenze Nuove and promoter of the project said several steps must be taken to integrate DTx into Italy’s healthcare system.

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Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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GMPSOP

AUGUST 10, 2023

Scope : This procedure applies to the training and development of all personnel within a GMP site including the documentation and retention of training records. Procedure Originator is responsible for determining who requires training on Document Change Notification (DCN). Annual refresher training shall be documented.

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pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data.

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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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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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Express Pharma

AUGUST 16, 2024

Dr Udaykumar Rakibe, Founder of PharmaMantra, presented on the practical applications of QRM, using real-world examples to explain risk assessment, control measures, and the importance of ongoing risk communication. He emphasised the role of detection in ensuring that substandard products do not reach patients.

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pharmaphorum

NOVEMBER 15, 2021

That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We This should cover the entire process, “starting with the writing, the review of the document, and its dissemination”.

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Eye on FDA

OCTOBER 19, 2022

The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern. Communicators and marketers would love black and white answers about concrete platforms. And they believe that the principles laid out to date cover pretty much any communications platform.

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FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Board Vitals - Pharmacist

DECEMBER 1, 2023

Patient Communication Some call it creating “happy patients,” others want to improve “patient experience,” and yet others mention “patient satisfaction.” Regardless of the term you use, communicating with patients in order to improve their care, compliance, and satisfaction is a worthy goal. It’s much easier said than done.”

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Pharma Pathway

JANUARY 24, 2023

Team Player and good Communications skills. Kindly Cary the below Documents: Updated Resume. •Experience in Characterization & Identification of Organic molecules using Spectroscopy techniques like NMR, IR, LCMS, HPLC. Positive and confident individual with strong work ethics. Ltd (Mallapur Unit), 2nd Floor, Plot No. Photocopy).

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PharmD Live

MAY 13, 2025

Unlike traditional fee-for-service (FFS) models that incentivize volume, APCM promotes proactive, longitudinal care rooted in coordination, communication, and continuity. These codesG0556, G0557, and G0558are billable once per patient per month, provided all documentation and service requirements are met.

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RX Note

JULY 15, 2023

Introduction Medical/case note entries are legal documentation of all contributions made by healthcare providers in a patient's care. It facilitates effective communication among healthcare providers by enabling the sharing of concise, informative and auditable records.

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GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

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pharmaphorum

AUGUST 19, 2021

The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. While the methods and approaches necessary to achieve these qualities will differ from trial to trial, their validity, said the document, is universal. Read the full document here.

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