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…

Documentation 144

Documentation 144

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 113

Documentation 113

Fierce Healthcare

OCTOBER 20, 2024

The Vertex AI Search for Healthcare tool is designed to make it faster for healthcare professionals and other employees to find critical information within health records and medical documents.

Documentation 103

Documentation 103

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.

FDA 98

FDA Documentation Method Validation Packaging 98

pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. The information was in an email sent in late November by a high ranking EMA official, which outlined a raft of issues.

Vaccines 138

Vaccines Documentation 138

IDStewardship

APRIL 13, 2023

PACCARB provides advice, information, and recommendations to the Health and Human Services Secretary (HHS) regarding programs and policies intended to support and evaluate the implementation of U.S. Today this Taskforce is known as The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, or PACCARB.

Hospitals 246

Hospitals Documentation Communication Patient Care 246

IDStewardship

OCTOBER 28, 2022

While the survey highlights most did not use social media when reviewing programs nor was it their primary information source, the authors concluded that residency program accounts can provide residency programs with a free additional tool for recruitment. Develop a manual or guidance document outlining the goals of the account.

Documentation 246

Documentation 246

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.

Hospitals 121

Hospitals Health Insurance Companies Documentation Insurance 121

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.

FDA 136

FDA Documentation 136

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.

Documentation 96

Documentation 96

Fierce Pharma

FEBRUARY 27, 2024

BioMarin has provided documents to the U.S. BioMarin has provided documents to the U.S. Department of Justice in response to a subpoena which requested information on the company’s government-sponsored testing programs for enzyme replacement therapies Vimizim and Naglazyme.

Documentation 74

Documentation 74

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year. The concern is that UK patients will face delays to receiving the latest medicines because of the changes to the regulatory system.

Documentation 124

Documentation Labelling 124

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.

Documentation 98

Documentation Communication 98

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.

FDA 119

FDA Documentation 119

IDStewardship

SEPTEMBER 2, 2022

In this article an expert in clinical information design provides his insights, discussing reasons why some guidelines do not get used along with solutions to these problems. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. BCPS, BCIDP.

Hospitals 130

Hospitals Documentation Formulary Information Medication Guidelines 130

European Pharmaceutical Review

JULY 1, 2022

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

Documentation 105

Documentation 105

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.

Documentation 98

Documentation 98

pharmaphorum

JULY 26, 2021

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. It also emerged that informed consent had not been collected. Click here for more information on PhRMA’s health equity programme.

Documentation 116

Documentation Hospitals 116

pharmaphorum

JANUARY 6, 2023

Sponsors running oncology and diabetes trials, for example, will ask for more information on patients’ real-life movements to demonstrate their quality of life, as well as efficacy and safety.”. Teams will develop, review, approve, and track content and documents more closely than ever, right down to version history and user access.

Documentation 111

Documentation FDA 111

IDStewardship

MARCH 12, 2023

Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant. This articles and the previous editions are great sources of information for what is happening in antimicrobial stewardship.

Medication Guidelines 299

Medication Guidelines Documentation Labelling Hospitals 299

pharmaphorum

JUNE 8, 2022

Other features include compatibility with Apple’s health data sharing facility, which allows information to be shared securely with healthcare staff or carers, and the ability to export a medications list into a PDF. For example, it can warn of possible issues like mixing drugs like metronidazole or cetirizine with alcohol.

Documentation 131

Documentation Labelling FDA 131

pharmaphorum

FEBRUARY 4, 2021

Over the years, Snapshot has grown into the industry’s most comprehensive toolset for org management, relational data migration, org documentation, technical debt removal, and profile and permission set management. . Documenting this information for every org can greatly improve Salesforce security, governance and compliance.

Documentation 105

Documentation 105

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. This document relating to microbiological methods is based on ANSI/AAMI ST72. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both. Why is bacterial endotoxin testing important?

Documentation 111

Documentation Labelling 111

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?

Documentation 98

Documentation 98

pharmaphorum

NOVEMBER 15, 2021

These must be submitted into the Clinical Trials Information System (CTIS), part of the EU Database, portal, no later than 12 months after the protocol-defined end of the study. The lay summary project, then, fulfils a “current and future need” to provide information in a “transparent, reliable, objective way”. Boosting engagement.

Documentation 98

Documentation Communication Hospitals 98

pharmaphorum

DECEMBER 23, 2021

The guidance gives advice on the design and selection of technologies that are suitable for use in trials, how they can be verified and validated as fit-for-purpose by the sponsor, and the sort of information that needs to be included in an application to start a clinical trial or seek marketing approval.

FDA 118

FDA Documentation 118

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.

Documentation 114

Documentation Communication Labelling Data Entry 114

pharmaphorum

JANUARY 26, 2023

The document from the Prescription Medicines Code of Practice Authority (PMCPA) arrives in the wake of several cases where drugmakers made promotional statements on social media platforms – including LinkedIn and Instagram – that were deemed to have breached the code of practice laid down by the Association of British Pharmaceutical Industry (APBI).

Communication 105

Communication Documentation 105

The FDA Law Blog

JUNE 10, 2024

Pre-BIMO Inspection Communication Best Practices The FDA may provide a pre-announcement notice to ensure that the necessary records and personnel are available during the inspection and includes general information about what the FDA plans to review. Submit documentation as evidence of addressing the observations (e.g.,

FDA 109

FDA Communication Documentation 109

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.

Documentation 93

Documentation 93

pharmaphorum

JANUARY 14, 2022

The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.

Documentation 126

Documentation 126

pharmaphorum

SEPTEMBER 28, 2022

A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device. “I O’Leary said.

FDA 135

FDA Documentation 135

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 98

Chemotherapy Documentation FDA 98

pharmaphorum

MAY 16, 2022

Waugaman joined USAID, in part, to help with a multi-year study looking at the global response to the Ebola outbreak and what the agency could learn from the use of data, digital systems, and information covering the global health and the humanitarian aspects components of that response. About the author.

Documentation 118

Documentation Vaccines 118

ISPE

MAY 1, 2023

It often took me multiple weeks of Computer Based Training (CBT) and reading documents. I created the templates in my own time and first only used them for my own information, as a reference book, instead of using the regulations to review compliance of CSV documents and controls. Several times I even didn’t pass the exams.

Documentation 98

Documentation 98

The FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. By Douglas B.

Documentation 97

Documentation FDA 97

Omnicell

JANUARY 10, 2023

Standardizing an interoperability solution that supports information exchange creates better medication management practices for nurses and improved patient engagement. The EHR-ADC interoperability automatically identifies variances between medications dispensed from the cabinet and those documented as being administered and drives action.

Omnicell 98

Omnicell Cerner Medication Dispensing Documentation 98