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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 Regulations, draft guidance, and other documents may be requested for public comment.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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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. This class-action litigation specifically focused on a 2011 licensing agreement between the two companies. These actions allegedly led to the extension of Novartis’ patents.

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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.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.