PharmTech

JUNE 23, 2025

From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs. FDA, USP Salt Policy (December 2014). 1, 2014 (accessed April 29, 2025). Selecting of the appropriate pharmaceutical alternative requires technical judgment. YouTube.com , Dec.

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PharmTech

JUNE 6, 2025

A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. With their technical and methodological improvements, advanced techniques provide valuable information on overall product mass profiles. Easton, R.L.

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Pharmaceutical Technology

JUNE 16, 2025

The US Food and Drug Administration (FDA) approved Amgen’s Blincyto (blinatumomab), the first bispecific T-cell engager (BiTE), in 2014 for adults with Ph- R/R B-ALL, with its label expanded in 2017 to include Ph+ and paediatric cases. Give your business an edge with our leading industry insights.

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European Pharmaceutical Review

MARCH 1, 2023

Nowhere is this more publicly evident than in the development, regulatory approval, and efficacious use of mRNA‑based vaccines for COVID-19. Beyond the high-profile COVID-19 vaccines, mRNA therapeutics are crucial in applications such as protein replacement therapies and regenerative medicine. 2014 Nov 20; 56(4), 506‑17.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Published July 2014. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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pharmaphorum

NOVEMBER 16, 2020

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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