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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?

Pharmacy Joe

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111
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Safe Handling of Hazardous Drugs

RX Note

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

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MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

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Case Study 2 – The Journey Leading to an Approved NDA

Syner-G

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?

Pharmacy Joe

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 52
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Case Study 6 – Regulatory Operations Department Developed and Flourishing

Syner-G

Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed. By early 2014, the Regulatory Operations group was fully operational and ready to offer electronic publishing services to IMPACT’s clients. The staff to manage and support this group was secured.

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How the Ukrainian clinical trial industry is overcoming disruption

Pharmaceutical Technology

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. CROs and sponsors use remote source document verification, as approved by the regulator pre-war. Using technology and decentralisation has also contributed.