FDA Law Blog: Biosimilars

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical Records 111

Medical Records Documentation 111

Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). This empowers care providers with critical patient information. This has been the case since long before the COVID-19 crisis.

Hospitals 130

Hospitals Communication Medical Records Dosage 130

pharmaphorum

SEPTEMBER 16, 2021

The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. Harnessing technology. Technology can also join up and improve services.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

pharmaphorum

OCTOBER 11, 2022

Therefore, to help contextualise study findings, external comparator arms (ECAs) can be employed, which compile data from external sources, such as patient registries and other medical records. However, methodological considerations must be undertaken to ensure the best conduct and minimise potential biases in ECA study designs.

Documentation 98

Documentation Medical Records Dosage Drug Development 98

FADIC

OCTOBER 20, 2023

     overall drug use and compliance;      the existence of extra risk factors for Increasing age ;      as well as prevention measures and evaluation of how to cope with emergency  situations. * What medication are prescribed by any specialists you may see?

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medical Records Medication Therapy Management (MTM) 52

pharmaphorum

SEPTEMBER 14, 2022

existing literature, public health, electronic medical records, demographics, etc.) An evidence-based approach can help sponsors tackle a long-standing issue with better informed diversity goals. As an initial step in planning future trials, sponsors can consider leveraging the breadth of data insights (e.g.,

Vaccines 98

Vaccines Medical Records Documentation Communication 98

pharmacy mentor

OCTOBER 22, 2024

PMR system – PMR systems are designed to provide comprehensive and up-to-date medication records for each patient and supports ​​better coordination with other healthcare providers. It also ensures that all relevant information is readily accessible, enabling pharmacists to make informed decisions and provide personalised care.

Communication 52

Communication Prescription Management Medication Dispensing Payment Processing 52

RX Note

MARCH 14, 2023

Document the antimicrobial therapy in the patient's medical record or medication chart, including the indication and the intended duration of therapy before further review or cessation. Example of patients with altered pharmacokinetics (e.g. before the availability of culture or susceptibility testing result).

Medical Records 52

Medical Records Hospitals Documentation 52

ID Stewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

Communication 90

Communication Medical Records Inpatient Documentation 90

Viseven

JULY 26, 2022

Apart from high-quality care, personalization, and transparency, patients are eager to have more control over their time and day-to-day health activities with easy access to accurate medical information. Medical calculators. For Medical Salesforce. Informational materials. Medical Education. Data Harvesting.

Health and Personal Care Stores 52

Health and Personal Care Stores Dosage Communication Prescription Management 52

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

Pharmaceutical Technology

JUNE 15, 2023

AI-based analysis can provide insight into participant behavior that informs how researchers design trials. AI can analyze this data in real time, allowing researchers to quickly identify trends and make informed decisions about how to proceed with trials. Improved access to knowledge has a direct impact on overall performance.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52

Pharmacy Joe

SEPTEMBER 6, 2021

I try to convey these recommendations privately and ‘off the grid’ with a sticky note or an informal conversation rather than in a written progress note or on patient care rounds. But for basic interventions like I just described, it makes the physician look good when they “fix up” orders based on your informal recommendations.

Hospitals 52

Hospitals Documentation Medical Records Inpatient 52

Viseven

JULY 16, 2024

Typically, data falls into two main categories: Traditional data includes information gathered through research, healthcare providers (HCPs), healthcare organizations, and public health agencies. For instance, health data might include information about an individual’s education, wearable sensor readings, or lifestyle habits.

Health and Personal Care Stores 52

Health and Personal Care Stores HIPAA Pharmaceutical Companies Pharmaceutical Companies 52

RX Note

JULY 30, 2023

Also, it is important to Document the ADR in the patient's medical record. For Malaysia, information on reporting adverse drug reactions can be found here. What other medicines can be used instead? Whether a dose reduction is feasible or practical. The ability to successfully treat the side effect.

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

PharmaShots

JUNE 2, 2023

Coding errors will most likely lead to n claim denials and delayed payments if medical necessity is not correctly represented or coding guidelines and best practices were not followed. THYNK assists in patient eligibility & pre-approval checks adding to it medical necessity & documentation checks.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Health and Personal Care Stores Medical Records Documentation 40

HealthPartners

AUGUST 23, 2022

They‘ve told me that because I've done my job, it’s easier for them to do their jobs because they know their patient's medication list is accurate." Informatics help MTM pharmacists improve treatment plans for patients as well as be more efficient when prescribing and administering medications.

Medication Therapy Management (MTM) 40

Medication Therapy Management (MTM) Diabetes Medical Records Hospitals 40

Pharmaceutical Technology

JUNE 20, 2023

Using AI in Electronic Medical Record systems AI already plays a significant role in Electronic Medical Records (EMR) which have evolved from being electronic versions of personal health records to providing deep AI-driven analysis that provides clinical decision support (CDS).

Medical Records 52

Medical Records Documentation Communication Dosage 52

Pharmaceutical Technology

APRIL 24, 2023

Sponsors must find and identify a set of subjects, gather information, and use inclusion/exclusion criteria to filter and select participants. Algorithms can gather subject information and screen and filter potential participants. AI can also alert medical staff and patients to clinical trial opportunities.

Documentation 52

Documentation Medical Records Communication Drug Development 52