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The FDA's requirements for non-IND Foreign Clinical Studies
The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided
the products and the clinical studies meet certain conditions. The types
of medical products that are permitted u...

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The increasing role of the social media in healthcare
the social media having moved beyond being a platform for sharing
personal information; its role in healthcare has nearly exploded of
late. This is mainly because the growth of the social media has more or
less coincided with that of the electronic...

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Technical Writing for the Pharma, Device and Biotech Industries
Technical writing for the IT industry is quite different from technical writing for the pharma, device and
biotech industries. Technical writing for the pharma, device and biotech
industries is a combination of skills and science. On the one hand, it

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Quality Risk Management in the FDA-Regulated Industry
Quality risk management in the FDA-regulated industry is a vital area of regulation for the FDA. Risks to quality may arise from many sources. The FDA has entrusted itself with the
responsibility of making sure that the quality of the products it

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Export, Import and Trade Compliance Principle – an understanding
Export, import and trade compliance principle is a very important guiding standard for governing trade policies and
ensuring compliance with the set national, regional and global trade
norms. It helps to define an organization’s adherence to the export,

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Data Mining and Signal Detection in Pharmacovigilance
A signal is described by the World Health Organization as any information that is reported on a possible or potential causal
relationship between a drug and the adverse event it spawns. This
relationship can be of virtually any nature, so long as it conce...

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What are the components of a Financial Audit Program?
There are various core components of a financial audit program . First, an understanding of a financial audit: A financial audit is a regular exercise carried out by qualified
professionals from within or outside, to check the financial health of
an organ...
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