Drug Topics

SEPTEMBER 17, 2022

But is the collected information being used to help with documentation, care planning, and reimbursement? Big data and analytics are everywhere—including in independent pharmacy.

Independent Pharmacies 225

Independent Pharmacies Documentation 225

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

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

Fierce Healthcare

FEBRUARY 28, 2024

LOS ANGELES — AI took center stage at the ViVE 2024 conference this week and health systems across the country are deploying the tech to tackle issues from easing the drudgery of medical docum | AI took center stage at the ViVE 2024 conference this week and health systems across the country are deploying the tech to tackle issues from easing the drudgery (..)

Documentation 134

Documentation 134

Colors Make me Happy

OCTOBER 24, 2023

A well-documented feature of trauma, one familiar to many, is the inability to emotionally articulate the experience. Below are some recommendations on how to become trauma informed 1. Seek out trauma-informed therapy. It is critical that those who have gone through traumatic experiences work with a trauma-informed therapist.

Documentation 52

Documentation 52

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 76

Documentation 76

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

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 114

Documentation 114

The FDA Law Blog

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.

Documentation 57

Documentation FDA Packaging 57

BioPharm

JUNE 21, 2024

The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.

Documentation 52

Documentation FDA 52

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 145

Documentation 145

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

The FDA Law Blog

DECEMBER 2, 2024

We have seen this come up in many device reviews over the last several years, so we are not surprised to see it make its way to the draft guidance, but the justification for this burdensome approach is not provided and having conflicting recommendations in two related documents (i.e.,

Documentation 52

Documentation FDA 52

DiversifyRx

SEPTEMBER 26, 2024

Documenting Business Meetings Having business meetings isn’t enough; you must document them properly if you want to protect your corporate veil. This documentation proves that your business decisions are made formally and thoughtfully rather than haphazardly. – Signatures: Have all attendees sign the document.

Independent Pharmacies 52

Independent Pharmacies Documentation 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.

Documentation 98

Documentation Communication 98

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.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

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.

FDA 57

FDA 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.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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 98

Documentation 98

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 124

Hospitals Health Insurance Companies Documentation Insurance 124

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

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

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

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

The FDA Law Blog

MARCH 7, 2023

Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission. This may result in the need to create additional documents that you may not necessarily need under the quality system.

Documentation 57

Documentation FDA Communication 57

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

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 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

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

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

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 120

FDA Documentation 120

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 139

FDA Documentation 139

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

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

Pharmaceutical Technology

SEPTEMBER 5, 2022

Factors such as increasing access to health information, the introduction of new medical treatments and technologies and the spike in birth rate are increasing the need for payers in the pharmaceutical industry. Documentation for a faster drug authorisation process. Finding the top payers in the pharmaceutical industry. .

Documentation 59

Documentation Hospitals 59

pharmaphorum

JANUARY 18, 2021

In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

Documentation 95

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 95

ISPE

AUGUST 17, 2023

Given the aforementioned information, it is critical to enhance the application of effective data governance and apply a framework for data structure by digitization software providers to ensure recent digitization tools do not “introduce other risks that may need to be controlled”.

Documentation 98

Documentation 98