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Five Lessons Learned About Antimicrobial Stewardship Metrics

IDStewardship

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

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Legal requirement, ethical duty: How to develop compliant, useful lay summaries

pharmaphorum

536/2014, due to come into force in February next year. That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We New lay summary guidelines walk sponsors through their obligations under EU regulation No.

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ISPE’s Regulatory Commenting Process

ISPE

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. HRSA sent a proposed regulation to the White House for approval but ultimately withdrew it in November 2014.

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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

FDA 52
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The imperative of fridge-free vaccines

European Pharmaceutical Review

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Available from: [link] q=US10821210B2. cited 2023July].

Vaccines 111
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

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. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Published July 2014.