Express Pharma

JANUARY 10, 2025

For example, GPS-enabled systems can log client visits, verify completed appointments, and document time spent at each location. GPS tracking helps sales organisations achieve these goals by providing a clear record of when and where sales representatives have been.

Documentation

Putting Patients First Blog

APRIL 21, 2025

Accessibility tools on event sites and transitioning from PDF to Word documents for meeting agendas. Schedule programming sessions to be 30 or 45 minutes long to accommodate attendees attention spans. Breaks after every session to allow attendees to reset and decompress. Using word forms and providing verbal descriptions of event space.

Documentation

Fuld & Company Blog

AUGUST 20, 2024

Increasing due diligence efficiencies: Leveraging NLP and Gen-AI models to examine large volumes of documents in a data room for specific items of interest, reducing costs and analysis time of due diligence teams. These can be powerful tools for investment banking support teams to improve transactional processes.

Documentation

Putting Patients First Blog

APRIL 8, 2025

The FDA should require that sponsors document mechanisms for post-market surveillance, root-cause investigation of errors or malfunctions, and audit trails that track data inputs, model updates, and user interactions. 56 ,57 ,58 Finally, comprehensive documentation is essential for reproducibility and public confidence.

Documentation

National Association of Boards of Pharmacy

JULY 23, 2025

Keep track of how often your system is being tested and how that testing is performed and documented. This blog post has been adapted from NABP’s presentation at the Asembia AXS25 Summit business session, Navigating the Accreditation Maze: Uncovering Common Deficiencies and Solutions.

Adverse Reactions

Express Pharma

MAY 22, 2025

Features like eCOA libraries with prebuilt instruments and the ability to autogenerate code and documentation accelerate development without sacrificing quality. Next-generation eCOA platforms not only minimise sponsor burden, but they also introduce tremendous end-to-end workflow efficiencies.

Documentation

pharmacy mentor

JUNE 23, 2025

Secure Document Uploads – Protects sensitive health data while enabling necessary file sharing. This keeps sensitive documents off of email or other forms of communication that could end up in front of the wrong person. Note Taking Feature – Allows pharmacists to document important details during interactions.

Health and Personal Care Stores

Pharmacy Joe

AUGUST 10, 2025

In the first year after implementation over 2000 results were called to the pharmacy and about one-third resulted in the pharmacist ordering an antimicrobial.

Pharmacy Technician

Express Pharma

AUGUST 12, 2025

Practical features of an Indian Orange Book Based on global best practices, a Saffron book i.e. Indian Orange Book should include: A searchable list of all approved drugs, by active ingredient, trade name, manufacturer, and dosage form, provide access to related documentation such as CMC, Labels etc.

Documentation

Express Pharma

APRIL 30, 2025

Project leaders should include robust risk management practices into daily project team routine to identify potential risks early, documenting them, and evaluating their potential impact and producing necessary mitigation plans with regular follow-up actions.

Communication

Express Pharma

JUNE 19, 2025

Based on our on-ground experience, the following patterns are frequently observed: Design basis weaknesses: Facilities often lack well-documented scientific rationales or fail to present a robust justification for design choices, procedural controls, and process parameters.

Documentation

Pharmacy Joe

JULY 23, 2025

While PPI-related adverse effects are well documented in the general population, evidence that describes these adverse effects in patients with chronic kidney disease is limited. Such adverse events include pneumonia, fracture, and even the development of type 2 diabetes and end-stage kidney disease.

Diabetes

Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. 22 ,23 Ultimately, these costs are absorbed by local hospitals, health care systems, and state and local governments.

Insurance Coverage and Processing

Pharma Marketing Network

APRIL 29, 2025

Neurological Conditions Miles Levin Filmmaker who documented his battle with glioblastoma. Rick Franklin Parkinson’s disease advocate sharing his journey through blogging. YouTube, Instagram, TikTok, and blogs are popular, but partnerships must be tailored to the platform where the influencers audience is most active.

Diabetes

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

Packaging

Express Pharma

JUNE 20, 2025

Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.

Documentation

Putting Patients First Blog

JUNE 26, 2025

4 Centers for Medicare & Medicaid Services, National Provider Communication Standards , April 15, 2025, https ://www.cms.gov/files/document/national-provider-communication-standards.pdf. https ://www.medpac.gov/document/june-2024-report-to-the- congress-medicare-and-the-health-care-delivery-system/. Joseph Mattingly II, Anthony A.

Drug Pricing

Express Pharma

JUNE 23, 2025

Most projects fail not in the lab, but in study design, regulatory interpretation, and documentation. However, in our experience at SG Pharma Solutions, more than 60 per cent of initial E&L submissions get flagged. The reason?

Packaging

RX Note

JUNE 15, 2025

The raw generic name itself is not used as the document key ID, since it can be lengthy and may include special characters that could lead to ID mismatches or errors in URL-based routing. The importance of setting this setup will be further explored in the later section of the blog post. Each row will typically represent a document.

Documentation

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. Stay tuned for the next iteration of the Cliffs Notes to the Cliffs Notes.

Documentation

PharmD Live

JUNE 2, 2025

Proven Track Record: Documented success, strong references, and positive client outcomes. Action Steps: Protecting Your Practice in 2025 Vet RPM Vendors Rigorously: Demand transparency, compliance documentation, and references. Full-Service Delivery: Education, device supply, and treatment management for every patient. link] AASM.

Documentation

Putting Patients First Blog

JULY 16, 2025

These resources should be published through open-access platforms, accompanied by clear documentation and appropriate licensing frameworks to support broad usability. Audit trails documenting model evolution, performance shifts, and retraining triggers should be maintained in publicly accessible registries.

Department of Veterans Affairs

PharmD Live

JUNE 23, 2025

PharmD Live’s board-certified clinical pharmacists manage and monitor the RPM service, record and document patient health metrics, and provide monthly billing reports, reducing provider workload without sacrificing care. PharmD Live blog. AMBCI Medical Billing & Coding Certification Blog. Published June 4, 2025. PharmD Live.

HIPAA

FDA Law Blog: Biosimilars

DECEMBER 15, 2024

In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. In fact, nearly all of the CMC comments are directing us to existing guidance documents. The guidance documents that CBER has issued in recent years in the CGT space have been important steps forward.

Documentation

PharmD Live

JANUARY 22, 2025

Tasks such as billing, coding and documentation consume valuable time and resources, pulling focus away from direct patient care. To stay viable, physicians must optimize revenue streams without compromising patient care. Administrative burdens add to these challenges.

Medication Therapy Management (MTM)

FDA Law Blog: Biosimilars

APRIL 22, 2025

DEAs Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents. We also regularly blog on DEA administrative cases and procedures (see here ), and our HPM attorneys have authored articles (see here and here ) on the DEA hearing process.

Controlled Substances

Putting Patients First Blog

JUNE 16, 2025

Developers should be required to: Conduct inclusive usability testing with older adults, people with disabilities, caregivers, and individuals with limited English proficiency; Share documentation of feedback collection and integration; and Comply with Section 508 and WCAG 2.1 Incentivizing the use of HL7 FHIR, OAuth 2.0,

Documentation

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Much of the debate on this issue centers on whether FDA can take photographs during an inspection (see our previous blog post ). Walsh & Hyman, Phelps & McNamara, P.C. & & Douglas B.

Documentation

EMCrit Project

JUNE 23, 2025

Most medical documentation is polluted with it, for want of using the persons actual name. EMCrit Blog. A few simple words by way of update can make all the difference. Say their name “The patient” is one of the most grating phrases in all of medicine, in my estimation. Published on June 23, 2025. Available at [[link] ].

Hospitals

Putting Patients First Blog

JULY 14, 2025

Alternative approaches—such as risk-based oversight models, streamlined documentation systems, and aligned quality reporting frameworks—may offer opportunities to reduce administrative burden while maintaining standards for care quality and safety. Question 4: What alternative approaches could achieve similar goals with less burden (e.g.,

Documentation

RX Note

JUNE 15, 2025

The raw generic name itself is not used as the document key ID, since it can be lengthy and may include special characters that could lead to ID mismatches or errors in URL-based routing. The importance of setting this setup will be further explored in the later section of the blog post. Each row will typically represent a document.

Documentation

Beckers Hospital Review

AUGUST 8, 2025

Dr. Arline leads patient safety, quality, analytics, documentation and infection control at BayCare Health System, a 16-hospital network. She launched a comprehensive clinical documentation improvement program, which resulted in enhanced revenue and performance on quality rankings. Laura Arline, MD. Krista Curell, JD, RN.

Hospitals

FDA Law Blog: Biosimilars

APRIL 10, 2025

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.

Documentation

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information.

Documentation

FDA Law Blog: Biosimilars

APRIL 14, 2025

As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards. When using ASCA, Summary Test Reports are included in a premarket submission using the format provided in the ASCA standards-specific guidance documents.

Documentation

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time.

Documentation

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). Details of the PCCP will be publicly available (i.e.,

Documentation