STAT

NOVEMBER 15, 2022

However, a STAT   review of documents detailing   the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants.

Vaccines 145

Vaccines Documentation 145

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. Food and Drug Administration and a manufacturer toward a controversial drug for reducing premature births, which the agency wants withdrawn from the market.

FDA 105

FDA Documentation 105

Fierce Healthcare

SEPTEMBER 15, 2021

Industry Voices—Not all automation is created equally for clinical documentation improvement. Wed, 09/15/2021 - 15:26.

Documentation 145

Documentation 145

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate. By Sophia R. Gaulkin — Last week, the U.S.

Labelling 59

Labelling FDA Documentation Packaging 59

BioPharm

MARCH 23, 2023

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Documentation 59

Documentation FDA 59

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

PioneerRx

MARCH 1, 2023

As pharmacists explore ways to get reimbursed for their services through a value-based care model, PioneerRx is right by your side with the ability to provide…

Documentation 52

Documentation 52

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 98

Vaccines Documentation FDA 98

Outsourcing Pharma

JANUARY 28, 2022

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

Documentation 69

Documentation FDA 69

Pharmacy Times

JULY 25, 2022

Once the revisions to become approved, there will be a minimum grace period of 6 months for pharmacies to comply.

Documentation 122

Documentation 122

BioPharm

JANUARY 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Documentation 40

Documentation FDA 40

Pharmafile

JANUARY 20, 2023

India-based manufacturer Intas Pharmaceuticals has been issued a Form 483 by the FDA after three investigators found a “cascade of failure” in a site inspection carried out at their manufacturing facility in Pharmez Special Economic Zone (SEZ) between late November and early December 2022. read more

FDA 94

FDA Documentation 94

BioPharm

SEPTEMBER 16, 2022

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

Documentation 40

Documentation 40

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

PhRMA

MARCH 29, 2023

This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

Insurance 293

Insurance Documentation 293

STAT

DECEMBER 16, 2022

My grandmother died in the hospital, alone, the day after she was “found down” at home by emergency medical services. I lived near my Nani, as I called her but, even though I am a physician, was not allowed to see her after she had been admitted to her local hospital because of the strict, Covid-related no-visitor policy.

Hospitals 116

Hospitals Documentation 116

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 131

Documentation 131

BioPharm

MAY 8, 2023

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

Documentation 52

Documentation 52

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

PhRMA

JANUARY 25, 2023

This report is the latest to document this progress. The report notes the continued decline in death rates since 1991, including a 1.5% decrease between 2019 and 2020 alone, increasingly reflects advances in prevention and treatment—including new medicines which have improved survival across a range of cancers.

Documentation 258

Documentation 258

STAT

JUNE 6, 2023

WASHINGTON — Medicare has chosen a Center for Medicare and Medicaid Innovation official to temporarily lead its implementation of Democrats’ drug pricing law, a document obtained by STAT shows.

Documentation 111

Documentation 111

STAT

JUNE 2, 2023

Monica Aissa Martinez really gets under her subjects’ skin — the final product is more medical map than pretty picture, documenting the elements (both scientific and ephemeral) that make a person unique. Read the rest…

Documentation 98

Documentation 98

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

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 89

Documentation Communication 89

STAT

MAY 17, 2023

Lawmakers in both parties have asked UnitedHealth Group, Humana, and CVS Health’s Aetna for internal documents that “will show how decisions are made to grant or deny access to care, including how they are using [artificial intelligence],” said Sen. Congress is ramping up its oversight, too.

Insurance 122

Insurance Documentation 122

STAT

JUNE 6, 2023

Notably, the FDA inspectors found a truck that was waiting for clearance to leave the facility and was carrying plastic bags that contained shredded documents. The inspectors found issues with data integrity and procedures designed to prevent microbiological contamination, among other problems.

Chemotherapy 105

Chemotherapy FDA Documentation 105

Pharmacy Times

JUNE 24, 2022

The impact of the pandemic on the mental health of health care workers, including pharmacists and pharmacy staff, has been well documented.

Documentation 182

Documentation 182

STAT

DECEMBER 14, 2022

An extensive investigation jointly published by The New Yorker and ProPublica documented outright fraud, predatory practices, and flagrant mistreatment by specific publicly traded and private equity-owned hospice companies. Hospice in America is gravely ill. Read the rest…

Documentation 145

Documentation 145

ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. This negates the requirement for storage of paper evidence and correct GMP document management of these hardcopy evidences.

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. Implementation of the ICH M10 document The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

Method Validation 87

Method Validation Documentation FDA 87

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

FDA 139

FDA Vaccines Documentation 139

ISPE

OCTOBER 28, 2022

Application of engineering change management (ECM), engineering document management, and engineering issue management throughout the C&Q process can significantly reduce time, cost, effort, and risk. Appropriate ECM and document management ensures that proposed changes are identified, assessed for impact, implemented, and verified.

Documentation 98

Documentation 98

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. Compliance — Regulators want to see consistent, GDocP-compliant, template-based documentation.

Documentation 98

Documentation FDA 98

Drug Topics

JANUARY 16, 2023

In the 3 cases documented by researchers, hepatitis B surface antigen (HBsAG) levels were reduced by more than 50% after Japan began its COVID-19 vaccination program.

Vaccines 98

Vaccines Documentation 98

STAT

APRIL 20, 2023

However, with the arrival of large language models like GPT-4, Bard, and LLaMA, there is growing enthusiasm for how AI might reshape the more mundane aspects of clinical practice: clinical documentation and electronic health records. And it’s obvious why. It really takes the feeling of care out of health care.

Patient Care 98

Patient Care Documentation 98

STAT

MARCH 30, 2023

The agency’s draft guidance outlines a new process in which the makers of AI tools could get approval for modifications in advance by submitting a document describing how the changes will be implemented and tested. Continue to STAT+ to read the full story…

FDA 116

FDA Documentation 116

STAT

APRIL 6, 2023

The investigation’s findings, detailed in a five-page document released by the company, note that none of more than 35 current or former employees interviewed reported observing or knowing of fraud related to the 2009 study in the journal Nature.

Documentation 126

Documentation 126