Compliance Resources to Help you Stay Current
Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.Categories
Compliance Trainings
By - Jeff Kasoff
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By - David Nettleton
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By - T.C Soli
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By - Betty Lane
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By - Charity Ogunsanya
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UK NHS Pharmaceutical Approval Body Rejects GSK’s Lupus Drug Benlysta
- Industry: Life Sciences
GSK’s new medicine for treating Lupus – Benlysta (generically known as ‘Belimubab’) was rejected by the UK National Health Service’s (NHS) drug rationing body. The drug was discovered by Human Genome Sciences and developed by Glaxo SmithKline (GSK) to combat the disease that causes the immune system to attack joints and organs. This article details why the drug was rejected and outlines the NHS drug approval process.
Factors to be Considered in Bio-Similar Product Development – Overview of FDA Draft Guidance
- Industry: Life Sciences
On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.
