European Pharmaceutical Review

JUNE 12, 2025

Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing. Data quality helps models produce better results and data scientists reduce their effort on debugging their informatics pipelines.

Drug Development

The Nontraditional Pharmacist

JULY 1, 2025

And then how do you develop documents to basically get approval from the FDA to study your drug in humans? So much smaller, much leaner and definitely more startup mentality. So there’s still definitely a lot of PharmD in there. So I definitely think looking for those types of roles with CROs.

Hospitals

European Pharmaceutical Review

JULY 15, 2025

The data challenge The research reveals a stark reality: 80 percent of pharmaceutical organisations surveyed report serious problems with either the availability or quality of data and documentation. “There was definitely a perceived risk of changing the ways of working practices.

Pharmaceutical Manufacturing

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

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.

Insurance Coverage and Processing

Pharmaceutical Commerce

AUGUST 14, 2025

Increased regulatory engagement highlights the importance of updating SOPs to ensure compliance and effective documentation of processes. Definitely new things that were being discussed, but also some familiar topics that we’ve talked a lot about in years past. Can you share documentation with me?

Insurance Coverage and Processing

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

Pharmacy Times

AUGUST 14, 2025

A definitive diagnosis of SPS often involves serological testing for specific autoantibodies. Adverse drug reactions should be documented using proper reporting systems when necessary. Diagnosing SPS usually involves a comprehensive neurological exam, which will evaluate muscle stiffness, spasms, and reflex abnormalities.

HIV Treatment and Prevention Agents

Putting Patients First Blog

JUNE 26, 2025

11 The role of patient-centered evidence in the renegotiation process also requires greater definition. 4 Centers for Medicare & Medicaid Services, National Provider Communication Standards , April 15, 2025, https ://www.cms.gov/files/document/national-provider-communication-standards.pdf. Joseph Mattingly II, Anthony A.

Drug Pricing

Proxsys Rx

APRIL 1, 2025

In a nutshell, says ProxsysRx 340B Optimization Manager Chance Spivey, the CE would have to pay retail prices first to allow for replenishment and THEN submit documentation like they do for 340B ESP (this time with even more claims info). Automate your 340B program with customized software streamlining documentation and reporting.

Specialty Pharmacies

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.

Documentation

Pharmacy Times

JULY 17, 2025

Patients were excluded if they had a primary mental health diagnosis of a substance use disorder or no documented Behavioral Health Initial Assessment Form in the electronic medical record. 8 By these definitions, more patients experiencing homelessness were sheltered than unsheltered ( Table 3 ).

HIV Treatment and Prevention Agents

Pharmaceutical Technology

JULY 11, 2025

Rare disease trials, by definition, struggle with small patient pools scattered across the globe. To learn more about the solutions provided by Paradigm Health, download the document below. To serve both science and patients, the industry must embrace transformation before inefficiency puts progress out of reach.

Drug Pricing

Pharmaceutical Commerce

JULY 16, 2025

Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. Implement and meticulously document robust quality control and assurance processes internally.

Compounding

Pharmacy Times

JULY 18, 2025

The definition of "essentially a copy" is pivotal, influencing compounding practices and legal interpretations. Compliance with FDA guidelines, including documenting clinical differences and avoiding investigational GLP-1s, is essential for compounders. Adopt best practices and document.

Compounding

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 CMS can accelerate access by: Expanding Blue Button 2.0

Documentation

Pharmacy Times

JULY 9, 2025

2 Evidence Supporting Supplementation A randomized controlled trial involving high-dose vitamin D (300 IU/kg/day, up to 5000 IU/day) in children with ASD documented meaningful improvements in Childhood Autism Rating Scale (CARS) scores, repetitive behaviors, eye contact, and attention after 4 months, without toxicity. 1-4 REFERENCES 1.

Pharmacy Technician

Pharmaceutical Technology

JULY 31, 2025

The document also confirms that deputy directors Scott Steele and Brittany Goldberg will continue to serve in their respective positions within the CBER executive committee.

Packaging

The Thyroid Pharmacist

AUGUST 1, 2025

135] I will definitely consider this if I have another baby. One product I’ve heard good things about was Visbiome’s infant drops (which sadly is not available at the time of writing). This is a multi-strain probiotic, and their research has found a 70 percent reduction in crying. [135]

Health and Personal Care Stores

Beckers Hospital Review

JULY 24, 2025

Waystar has signed a definitive agreement to acquire AI-powered revenue cycle management company Iodine Software. The proposed $1.25 billion deal will be funded with a 50/50 mix of cash and stock consideration, according to a July 23 Waystar news release.

Documentation

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Upon receipt of the 513(g), FDA will assess whether the product meets the definition of a device under section 201(h) of the FD&C Act. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country.

Documentation

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks. PMA summary of safety and effectiveness document (SEED) and approval order, 510(k) Summary, De Novo decision summary).

Documentation

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation

ALiEM - Pharm Pearls

APRIL 5, 2023

Does this come at the expense of your documentation? The amount that I teach definitely depends on patient volume. What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I usually text them if it’s after shift, or talk to them on shift about their documentation.

Documentation

ALiEM - Pharm Pearls

MARCH 29, 2023

Well-appearing febrile infants The AAP acknowledges that clinician experience is likely the best determinate of what is “well-appearing”, further admitting that there is no measure or definition of either “experience” or “well-appearing” Febrile Rectal temperatures of 38.0C What should be done if the viral panel is positive ?

Hospitals

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation

FDA Law Blog: Biosimilars

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. The final guidance provides additional discussion with respect to DHTs that meet the definition of a device.

Documentation

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device.

Documentation

pharmaphorum

SEPTEMBER 29, 2022

Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. If so, developers must develop and execute on a regulatory strategy. This approach is known as exercising enforcement discretion. not a medical device, ii. 360c(g)).

Documentation

ALiEM - Pharm Pearls

MARCH 8, 2023

Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. My review is post-shift.

Documentation

European Pharmaceutical Review

JULY 5, 2023

Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots. In February 2023, the PDA released its Technical Report 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing.

Pharmaceutical Manufacturing

pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Criteria for regulation.

Documentation

pharmaphorum

JANUARY 28, 2022

It all just comes down to definitions. Much ink has been spilled about the fact that “digital health” as a category has no standardised definition. And if it’s hard to definitively separate companies into “digital health” and “not digital health”, it’s even harder to subdivide those companies into categories.

Documentation

pharmaphorum

OCTOBER 11, 2022

In addition, RCTs don’t have to rely on two different data sources, which may have different operational definitions, assessment methods, and measurement timing. Documentation of detailed descriptions of the ECA population is critical, including the mechanisms and conditions that led to the patients being recorded in the data source.

Documentation

FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions.

Documentation

European Pharmaceutical Review

SEPTEMBER 13, 2023

This will allow these firms to complete administrative procedures across the Single Market without needing to re-submit documents. Simplify administrative procedures and reporting requirements for SMEs by launching the Once-Only Technical System (part of the Single Digital Gateway ) by the end of 2023.

Communication

Pharma in Brief

JANUARY 12, 2022

Removal of documents improperly filed: A document may be ordered removed from the judicial record on the grounds that it is scandalous, frivolous, vexatious or clearly unfounded. The definition of “Christmas recess” has been replaced with the more inclusive “seasonal recess”.

Documentation