The FDA Law Blog

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Documentation 104

Documentation FDA Adverse Reactions Communication 104

Fierce Pharma

AUGUST 28, 2023

It’s been well documented how Novo Nordisk has had difficulty in meeting the soaring demand for its GLP-1 weight loss treatments.

Documentation 92

Documentation 92

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

pharmaphorum

MAY 25, 2022

When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.

Documentation 105

Documentation Communication Labelling 105

European Pharmaceutical Review

AUGUST 3, 2023

Rather than focusing on documentation with the aim to achieve compliance, the initial proposed framework shined a light on problem-solving and therefore the initiation of preventative action as a key part of the process. These results are included in most recent paper.

Documentation 52

Documentation Process Improvement FDA 52

European Pharmaceutical Review

APRIL 10, 2024

The regimen may be applied as a quality indicator fulfilling certain ISO quality control criteria, and offers “documented, systematic feedback”. Additionally, a laboratory could assume that a partially degraded nucleic acid “is a consequence of upstream preanalytical events rather than contamination in their laboratory”.

Documentation 96

Documentation 96

The FDA Law Blog

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 62

Labelling FDA Communication Documentation 62

Viseven

SEPTEMBER 6, 2024

Key Principles of Data Integrity In the 1990s, the FDA developed a list of principles of data integrity, which still serve as a framework for working with data and documenting it. With contemporaneous data documentation, it becomes possible to easily avoid any errors and inaccuracies that might come up after data recordings take place.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Data Entry Pharmaceutical Companies 52

European Pharmaceutical Review

JUNE 12, 2024

MBK-01 demonstrated a greater clinical benefit than fidaxomicin when used as the first choice for treatment of the current CDI episode event without any antibiotic treatment. Additionally, MBK-01 did not increase the frequency of adverse events (AEs) commonly associated with CDI or antibiotic treatment and was well tolerated.

Documentation 111

Documentation Labelling Hospitals 111

PQA

MARCH 8, 2024

We are in the early stages of planning an event, PQA Convenes: Quality Medication Use in Rare Disease, which will bring our members and the rare disease community together to explore quality in medication use. This one-day event will take place on Thursday, November 7, 2024, in Arlington, Va., Learn more below.

Community Pharmacies 52

Community Pharmacies Specialty Pharmacies Independent Pharmacies Documentation 52

PQA

DECEMBER 14, 2023

Informed by a robust environmental scan and a November 2 national convening event, PQA has drafted a call to action that includes eight elements. Strengthen requirements for standardized documentation and reporting related to the quality of MTM services. You can read more about each of these in the draft call to action document.

Documentation 45

Documentation 45

pharmaphorum

DECEMBER 10, 2020

FDA reviewers have already concluded that the vaccine is safe and effective in a briefing document ahead of the Vaccines and Related Biological Products Advisory Committee’s meeting.

Vaccines 94

Vaccines Documentation FDA 94

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 106

FDA Documentation Vaccines 106

pharmaphorum

MAY 5, 2022

Following on the success of the previous West Coast events, we are delighted to announce 5th Annual Pharmaceutical Microbiology West Coast conference taking place in San Diego on June 20th and 21st,2022. Event Hashtag: #PharmaMicroWC. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab. Key Reasons to Attend: 1.

Documentation 52

Documentation 52

The Checkup by Singlecare

NOVEMBER 9, 2023

This person may go by other names in the document, depending on the state you live in. The benefits of a medical power of attorney Having a signed and notarized medical power of attorney offers many perks, and it is one of the most important documents you’ll create in a lifetime.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Communication Hospitals 52

pharmaphorum

JANUARY 6, 2023

Kelly Traverso, vice president, Veeva Vault Safety Strategy, and consulting, predicts that “in 2023, companies will broaden their focus beyond safety data to include all the content and documents that come with it. Improved control reduces the risk of misinformation, or having teams send outdated or incorrect information to partners.”.

Documentation 111

Documentation FDA 111

Hospital Pharmacy Europe

JANUARY 4, 2023

Being infected with herpes zoster increases the long term risk of a major cardiovascular event such as a stroke and the development of coronary heart disease, according to an analysis from three large, prospective studies by researchers from Harvard Medical School, Boston, US. Herpes zoster infection and cardiovascular events.

Medical Schools 52

Medical Schools Documentation Hospitals 52

PQA

SEPTEMBER 25, 2023

This invite-only event will bring together PQA members and industry experts to discuss the state of medication therapy management (MTM) practice, implications of recent Centers for Medicare & Medicaid Services (CMS) proposals and opportunities to evolve MTM quality measurement. The survey and environmental scan will inform PQA Convenes.

Documentation 40

Documentation 40

Omnicell

JANUARY 10, 2023

So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? It’s well documented that manual processes are archaic and inaccurate, and organizations like ISMP, ASHP, and many others agree things need to change. Or the airlines lost 10% of passenger bags.

Sterile Compounds 52

Sterile Compounds Compounding Omnicell Documentation 52

PQA

MARCH 22, 2023

This in-person, one-day event, “PQA Convenes: Advancing the Quality of Medication Therapy Management,” will take place at the Renaissance Arlington Capital View, in Arlington, Va., This special event precedes the 2023 PQA Leadership Summit, which is November 2-3 at the same location. from 9:00 a.m.-2:00 data sources), and usability.

Documentation 52

Documentation 52

European Pharmaceutical Review

JANUARY 19, 2023

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. Adverse events (AEs) observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.

Hospitals 96

Hospitals Documentation 96

Hospital Pharmacy Europe

AUGUST 7, 2023

In 2008, the American Society of Health-System Pharmacists published a document outlining the activities that pharmacy services in EDs should provide, which was subsequently updated in 2021. Involving pharmacists in care coordination reduces adverse events and eliminates unnecessary medical costs.

Patient Care 98

Patient Care Hospitals Documentation 98

ISPE

APRIL 19, 2023

Organize and plan the work: identify who is going to do each task, specify the deadlines to deliver, estimate the available resources, and foresee how to react to possible unforeseen events. This strategy, and which test is susceptible to carry it out or not, must be set out in a document and this activity corresponds to the PM.

Documentation 52

Documentation Communication 52

The Checkup by Singlecare

JUNE 28, 2024

It’s also approved to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease. Managing blood sugar and reducing the risk of major adverse cardiovascular events in people with Type 2 diabetes are the only FDA-approved uses for Ozempic.

Insurance 96

Insurance Insurance Coverage Labelling Medical Records 96

Hospital Pharmacy Europe

AUGUST 17, 2023

11,12 In addition, due to the complexity of these therapies, pharmacists must ensure adequate training during their implementation, management and monitoring of toxicities and adverse events, and effective collaboration with all members of the multidisciplinary team.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

pharmaphorum

JULY 15, 2022

The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood who are already taking statins.

Documentation 98

Documentation 98

pharmaphorum

OCTOBER 12, 2022

Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred. Presentation of data is vital when regulators carry out formal inspections.

Documentation 100

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 100

The FDA Law Blog

OCTOBER 3, 2022

Mr. Bawduniak claimed that these events were held at “sumptuous resorts and restaurants” and involved “lavish meals and free alcohol.” Today, these two documents are key in navigating speaker programs in the industry.

Documentation 104

Documentation 104

The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

FDA 104

FDA Documentation 104

PQA

SEPTEMBER 25, 2023

We continue to play a central role in driving meaningful improvements and positive changes related to medication safety, adherence and appropriate use.The 2023 PQA Annual Report documents our progress towards Blueprint PQA 2025. These events is an invitation-only event for PQA member organization leaders.

Specialty Pharmacies 52

Specialty Pharmacies Documentation Patient Care Immunization 52

pharmaphorum

JANUARY 13, 2023

At the moment the threshold for prescribing these drugs to a patient is a 10% or greater risk over 10 years of a cardiovascular event such as a heart attack or stroke. A daily 20 mg does of atorvastatin – available as a low-cost generic – is the statin of choice for primary prevention, according to the document.

Documentation 52

Documentation 52

PQA

NOVEMBER 14, 2024

The 2024 PQA Annual Report documents our progress towards the plan’s goals. “Goal two of our strategic plan is to advance the quality of pharmacist-provided care and services that optimize medication use, adherence and safety.  Sign up to receive updates on all of PQA’s convening events. 

Specialty Pharmacies 52

Specialty Pharmacies Documentation Patient Care Immunization 52

PQA

JULY 28, 2023

For patients with multiple chronic conditions and taking many chronic medications, MTM can help achieve the best therapeutic outcomes while reducing the risk of adverse events. We plan to open registration for this invitation only event on August 15, and we’ll share more details at that time.

Documentation 40

Documentation 40

pharmaphorum

OCTOBER 7, 2022

As we enter October and the Frontiers Health 2022 conference in Milan, we’re shining a spotlight on some of the Steering Committee members who have helped make the event what it is. And check out DTx and National Health Systems from last year’s event below. A cooling off in digital health investment. “Yet,

Documentation 98

Documentation Insurance 98

PQA

JULY 28, 2023

A key part of this effort is a November 2 PQA Convenes event will will host. Community events are also popular. We plan to open registration for this invitation only event on August 15 and will share more details at that time. Event and registration details will be shared in the coming weeks. Learn more below.We

Documentation 40

Documentation Vaccines 40

PQA

JUNE 16, 2023

Learn more about this convening event below. This in-person, one-day event, “PQA Convenes: Advancing the Quality of Medication Therapy Management,” will take place at the Renaissance Arlington Capital View, in Arlington, Va., Additional information about this PQA Convenes event will be shared by August. on November 2.

Documentation 40

Documentation Vaccines 40

European Pharmaceutical Review

JULY 21, 2023

The document is part of the joint Heads of Medicines Agencies (HMA)-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines Regulatory Network’s capability in data-driven regulation. How can AI be best harnessed for pharmacovigilance data?

Documentation 98

Documentation FDA 98