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 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 72

Documentation 72

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 97

Documentation 97

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 133

Documentation 133

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

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 91

Documentation Communication 91

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 59

FDA Documentation Labelling Communication 59

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 83

Documentation 83

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 94

Documentation 94

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 103

FDA Documentation 103

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 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 121

FDA Documentation 121

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

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 92

Documentation 92

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 90

Chemotherapy Documentation FDA 90

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

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

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

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 101

Documentation 101

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 78

Documentation 78

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 96

Documentation Labelling 96

The FDA Law Blog

APRIL 19, 2023

The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD). x 11-inch paper, and with hyperlinks to references and numbered pages.

Documentation 59

Documentation FDA Labelling 59

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 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 99

Communication Documentation 99

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 78

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 78

The FDA Law Blog

FEBRUARY 7, 2023

For PMA devices, the marketing application contains quality system and manufacturing information, so getting started on the quality system in parallel to device development is important for a timely submission. There are many resources that provide information and guidance for each of these required elements.

Documentation 98

Documentation FDA Labelling 98

The FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are.

FDA 105

FDA Documentation Medical Records 105

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

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 129

Vaccines Documentation 129

The FDA Law Blog

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.

Controlled Substances 116

Controlled Substances Documentation 116

The Physician Pharmacist

MAY 16, 2023

He explains that clinical informatics focuses on one-on-one interactions with patients and how to improve the user interface to make the documentation process more seamless. One of the most significant benefits is improved interoperability , which allows healthcare professionals to share patient information more easily.

Documentation 52

Documentation Patient Care Mayo Clinic Communication 52

The Checkup by Singlecare

DECEMBER 13, 2022

Once you’re ready to appeal, write a letter including all the necessary information for an appropriate review of your claim. Noor Ali, MD, founder at Dr. Noor Healthcare Advisor , says that it also includes “strong supportive documents, [like] medical evidence, clinical notes, professional statements,” and more. Sending the letter.

Insurance 98

Insurance Documentation Insurance Coverage HIPAA 98

ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

Documentation 52

Documentation Communication 52

Hospital Pharmacy Europe

FEBRUARY 1, 2024

‘As there have been significant changes, it is strongly recommended that all definitions are read and understood to assist in the interpretation of the standards themselves and the document should be read in full,’ the Standards’ introduction says.

Documentation 52

Documentation Hospitals Patient Care 52

pharmaphorum

DECEMBER 19, 2022

This approach, which relies on home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs and electronic informed consent, has the potential to make clinical trials available to a wider demographic of participants and reduce drop-out rates, they add.

Documentation 70

Documentation 70

Impact Pharmaceutical Services

OCTOBER 27, 2023

The IND application must include information in three broad areas: animal pharmacology and toxicology studies, manufacturing information, and clinical protocols and investigator information. [1] Poor documentation. Accurate and complete regulatory documentation is vital to IND application success.

Documentation 52

Documentation FDA 52

ISPE

SEPTEMBER 14, 2022

introduces it thus: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action. Wikipedia 2.

Documentation 97

Documentation Communication 97