European Pharmaceutical Review

FEBRUARY 1, 2023

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation.

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Documentation 104

STAT

OCTOBER 25, 2023

Novartis has gone to court to gain access to Takeda Pharmaceutical documents over concerns that a former employee took trade secrets with him to his new job at the rival drugmaker. Continue to STAT+ to read the full story…

Documentation 263

Documentation 263

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

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Documentation Labelling Communication 104

pharmaphorum

NOVEMBER 13, 2020

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process. Focus on ensuring high quality documentation.

Documentation 52

Documentation 52

Drug Patent Watch

MARCH 25, 2020

link] Drug developers require access to scientific information in…. The post Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average appeared first on DrugPatentWatch - Make Better Decisions. Unported License.

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Documentation Drug Development 54

Putting Patients First Blog

JULY 1, 2024

General Comments: The NHC commends CMS for its efforts in revising the MPPP model documents to enhance clarity, accessibility, and beneficiary engagement. Additionally, to further enhance the effectiveness of the documents, we recommend the formal establishment of a feedback loop and periodic reviews.

Documentation 52

Documentation Communication Payment Processing 52

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

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Documentation Method Validation Compounding Data Entry 52

GMPSOP

AUGUST 13, 2023

Simply ensure that information about the components is recorded (as is). The information must be sufficient to allow the components to be replaced and reconfigured to resume operation as soon as possible if necessary. Lack of adequate records will cause costly delays, errors and in some cases possible unwanted actions from regulators.

Documentation 40

Documentation 40

STAT

JANUARY 11, 2024

Generative AI’s earliest applications in medicine have largely focused on curing not patients, but the plague of productivity physicians lose to digital documentation. Read the rest…

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Documentation 348

National Association of Boards of Pharmacy

MARCH 22, 2024

Food and Drug Administration (FDA) has issued two draft interim guidance documents that address the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Documentation 52

Documentation Compounding 52

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.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

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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Documentation Data Entry Communication Packaging 40

STAT

JULY 10, 2024

This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition. The Biden administration on Wednesday proposed an annual rule that sets payment rates for hospitals.

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Hospitals Health Insurance Companies Documentation 283

STAT

NOVEMBER 10, 2022

In court documents, federal authorities alleged that Ramkumar Rayapureddy, the chief information officer at the drug company, which was previously known as Mylan, provided “material” information to Dayakar Mallu, who also worked in the IT department.

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Documentation 226

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.

Documentation 52

Documentation Health and Personal Care Stores Medical Records Communication 52

STAT

JANUARY 20, 2023

Federal Trade Commission asked a federal judge to hold “pharma bro” Martin Shkreli in contempt for failing to provide the agency with information needed to determine whether he is violating an order that permanently banned him from working in the pharmaceutical industry.

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Documentation 241

Pharma Leaders

JUNE 27, 2023

Also available: Take advantage of our multi-user and site licenses of FDAnews , so you’ll have the most-informed workforce! Start your single-user one-year subscription (250 issues) FDAnews for only $1,895. Contact Will Tuttle, Business Development Representative at wtuttle@fdanews.com or +1 612.216.2948 to receive a custom quote.

Documentation 52

Documentation 52

STAT

OCTOBER 20, 2023

The list of AI devices was first published after a STAT investigation reported that the FDA had failed to keep the public informed on its regulation of AI devices, or crucial details on the tests undertaken to prove their safety and effectiveness.

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Documentation 279

STAT

SEPTEMBER 25, 2023

The Food and Drug Administration said Monday that it has deep reservations about NurOwn , an investigational ALS treatment from BrainStorm Cell Therapeutics, citing a lack of evidence that the medicine works and the company’s failure to demonstrate that it can properly manufacture the product.

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Documentation 323

STAT

AUGUST 1, 2023

Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility. Another employee failed to report all test results on product samples and, at times, printouts were tossed in the trash.

Chemotherapy 238

Chemotherapy Documentation 238

STAT

MAY 10, 2023

She requests to fill out paper forms instead of digital ones; she documents and tracks what she signs. Alex Rosenblat is particularly careful when it comes to her digital privacy. But even her diligence can’t always save her.

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Documentation 215

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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Documentation Method Validation Packaging Labelling 98

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

The NDRP focused on six strategic objectives one of which was the implementation of the Integrated Assessment which per CDER was designed to “critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements.” 89 FR 74966 at 74968 (Sept.

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Documentation Packaging 57

Express Pharma

JUNE 7, 2023

BASF Pharma Solutions and the Life Science business of Merck KGaA, Darmstadt, Germany announced the launch of a new standard for the electronic transfer of quality and regulatory documentation from suppliers to users in the pharma/biopharma industry.

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Documentation 96

Big Molecule Watch

AUGUST 20, 2024

On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”). For the time being, the FDA asks two questions.

Biosimilars 57

Biosimilars Documentation 57

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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Documentation Communication 52

Pharmaceutical Commerce

JANUARY 26, 2024

The Identification of Medicinal Product framework seeks to establish a common language for identifying, documenting, and exchanging information about medicinal products.

Documentation 52

Documentation 52

Putting Patients First Blog

JULY 22, 2024

These dimensions will often vary based on patients’ unique circumstances and must be informed by patient engagement. 2 Patients’ unique experiences and preferences provide critical information that can inform more effective and equitable research and access strategies.

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Documentation Vaccines 52

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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Documentation Communication 98

Pharma in Brief

JANUARY 8, 2024

The Court now expects parties to proceedings before the Court to inform it, and each other, if they have used AI to create or generate new content in preparing a document filed with the Court. Types of documents. For example, AI that only follows pre-set instructions ( e.g. , document editing or voice recognition).

Documentation 52

Documentation 52

Viseven

JULY 10, 2024

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. Imagine a game of telephone, but instead of funny phrases, we’re passing along critical medical information.

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Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH.

Documentation 57

Documentation Labelling Communication 57

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Over the years, pharmaceutical companies seeking product approvals have submitted increasingly vast amounts of information to regulatory agencies.

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Documentation Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

PioneerRx

MARCH 1, 2023

PioneerRx’s pharmacy software includes Lab functionality to document patient health information… Looking to provide your patients with an enhanced level of care?

Documentation 52

Documentation 52

STAT

SEPTEMBER 26, 2023

The FDA disclosed it has deep reservations about NurOwn, an investigational ALS treatment from BrainStorm Cell Therapeutics, citing a lack of evidence the medicine works and a failure to demonstrate the company can properly manufacture the drug , STAT writes.

Documentation 224

Documentation 224

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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Documentation Customer Service Health and Personal Care Stores Communication 59

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

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Documentation Pharmaceutical Manufacturing 98