Express Pharma

AUGUST 12, 2025

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. Clear marking of innovator and approved generic products. Addressing potential concerns and implementation challenges.

Documentation

European Pharmaceutical Review

JUNE 12, 2025

Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. 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.

Drug Development

Putting Patients First Blog

JUNE 26, 2025

This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. 4 Centers for Medicare & Medicaid Services, National Provider Communication Standards , April 15, 2025, https ://www.cms.gov/files/document/national-provider-communication-standards.pdf.

Drug Pricing

GMPSOP

JUNE 15, 2025

Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Check out sample preview s.

Pharmaceutical Manufacturing

Pharma Marketing Network

MARCH 18, 2025

Avoiding misleading claims or unapproved off-label promotions. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits. Best practices include: Clearly stating the drug name, indications, and fair balance information.

Pharmaceutical Companies

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? And ultimately, it’s to ensure we get the data because the data are ultimately what turns into your FDA approved label and demonstrates what you need. And then paramount, obviously, is patient safety.

Hospitals

Pharmacy Times

AUGUST 12, 2025

Image Credit: catalin | stock.adobe.com STARGLO Trial Overview Study Design and Population STARGLO was a global, randomized, open-label, phase 3 trial enrolling 274 patients across 62 centers in 13 countries. 7015 FDA Advisory Committee Briefing Document: Columvi (glofitamab-gxbm) plus GemOx. month follow-up was 13.5 (7.9-18.5)

Pharmacy Technician

Pharmacy Times

JULY 22, 2025

This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. Real-World Evidence, Emerging Therapies, and Demonstrating Value Technological advances are accelerating this progress.

Pharmacy Technician

Express Pharma

JULY 23, 2025

He outlined critical compliance points across the API lifecycle—from vendor approval, material flow, and personnel hygiene, to facility design, labelling control, and computerised system validation. The session concluded with a strong push for systematic documentation and continuous compliance vigilance in line with global GMP.

Packaging

Pharmacy Times

JULY 2, 2025

The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

Pharmacy Technician

Viseven

JUNE 18, 2025

Compliance & documentation : Ensuring scientific interactions, data sharing, and materials comply with regulatory and ethical standards, monitoring for compliance risks. Label expansion Label expansion is an important but costly process of gaining regulatory approval for new indications, patient populations, or dosing regimens.

Labelling

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

Documentation

Pharmacy Times

AUGUST 7, 2025

Document stamped with "FDA Approved" next to magnifying glass | Image Credit: © aznan - stock.adobe.com CLL/SLL prognoses have greatly improved over the past few decades with the emergence of novel targeted therapies and immunotherapies. 1 Birelentinib has demonstrated favorable clinical benefit across multiple clinical trials.

HIV Treatment and Prevention Agents

Pharmaceutical Commerce

JULY 16, 2025

Existing policies often feature explicit exclusions for non-FDA approved products or harm from off-label use. Implement and meticulously document robust quality control and assurance processes internally. For the few willing to offer coverage, 5 premiums are substantially elevated with higher deductibles.

Compounding

PharmaTech

JULY 17, 2025

Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Finalize documentation with full traceability and ensure preparations are quarantined until verified.

Compounding

EMCrit Project

JUNE 23, 2025

Most medical documentation is polluted with it, for want of using the persons actual name. Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* A few simple words by way of update can make all the difference.

Hospitals

Pharmaceutical Technology

JULY 15, 2025

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

Packaging

pharmaphorum

JULY 7, 2025

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring.

Insurance Coverage and Processing

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. 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

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

Documentation

EMCrit Project

JUNE 16, 2025

Intubated patients in the ED should have soft, wrist restraints places without the need for arduous, high-risk documentation or sitters Intubation Checklist EMCrit 176 – Updated EMCrit Rapid Sequence Intubation Checklist Awareness during Paralysis EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

Labelling

FDA Law Blog: Biosimilars

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. If data are excluded because of data quality issues, the rationale and criteria for the exclusions should be documented in the DCP.

Documentation

FDA Law Blog: Biosimilars

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

Labelling

GMPSOP

APRIL 3, 2023

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

Documentation

pharmaphorum

JANUARY 20, 2022

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

Documentation

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation

European Pharmaceutical Review

AUGUST 23, 2022

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

Documentation

Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling

PharmaTech

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year.

Documentation

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both. This document relating to microbiological methods is based on ANSI/AAMI ST72. Why is bacterial endotoxin testing important?

Documentation

PharmaTech

OCTOBER 18, 2024

Rather than relying on a myriad of different systems, the author proposes that a cloud-based solution can control and coordinate everything, allowing manufacturers to deftly respond when changes in labeling requirements arise.

Labelling

pharmaphorum

MAY 25, 2022

Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. Identifying the appropriate code and label. The codes still apply. End of the host country.

Documentation

pharmaphorum

APRIL 28, 2021

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

Labelling

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Documentation

pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data. Label Authoring and Tracking.

Documentation