Pharmaceutical Technology

SEPTEMBER 15, 2022

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

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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.

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Drug Pricing Communication Drug Development Documentation 52

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

On July 7, 2023, armed with these new procedures, CDER notified Oncopeptides that it proposed expedited withdrawal of Pepaxto because the postapproval study failed to verify clinical benefit and because Pepaxto was not shown to be safe or effective under its conditions of use (the documents discussed herein are published in the docket here ).

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Documentation Labelling Drug Development 59

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. The worldwide trend of using botanical drugs and strategies for developing global drugs.

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Drug Development Documentation Labelling Biosimilars 103

Putting Patients First Blog

APRIL 7, 2025

At the same time, as insights generated by AI increasingly shape the selection of drug targets, biomarkers, or dosing strategies that inform regulatory submissions, it is essential that any AI-derived outputs used to support regulatory decision-making meet appropriate standards of empirical validation and scientific transparency.

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

The Nontraditional Pharmacist

JULY 1, 2025

So that group was really focusing on helping clients develop their regulatory strategy as they think about bringing a drug into development, what does that look like? And then how do you develop documents to basically get approval from the FDA to study your drug in humans?

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Hospitals Packaging Documentation Labelling 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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Packaging Documentation Labelling Communication 59

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Discussion topics Part two of this series ( click here for part one ) addresses numeric calculations for types of bulk drugs. Pluta Nishant B.

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Compounding Dosage Labelling Drug Development 52

PharmaTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. It uses terms like “to the extent possible”, thus allowing for methodological developments pushing the ability to detect structural details in ever greater and more precise ways.

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Dosage Drug Development Documentation Biosimilars 52

FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. For drugs, the relevant CDER/CBER Division may or may not provide feedback; sponsors with specific questions may include them as a topic for discussion in meetings with FDA.

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Drug Development Communication Documentation Labelling 59

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. LaNova’s drug development focuses on tumour immunity and the tumour microenvironment. by market close.

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BioPharma Dive

JUNE 5, 2025

Other tasks performed by Elsa included “summarizing adverse events to support safety profile assessments, conducting expedited label comparisons and generating code to facilitate the development of databases for nonclinical applications.” “One scientific reviewer told me what took him two to three days now takes six minutes.”

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Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing 52