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FDA’s eCTD Mandate: Are You Ready?

When FDA posted their eCTD mandate last year, it was more of a whisper than a bang.  It certainly did not wreak havoc in the industry; after all, we were all warned that the time would come sooner rather than later. The deadlines are quite clear: After May 5, 2017 The following submission types must …

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The Future of Health Impact Assessment (HIA): Realizing its Potential

Health is an odd concept. What does it mean to be healthy? Are there different meanings of the word health? Is health an objective or subjective idea? These are questions that have been discussed and debated for decades. Traditionally, when people talked about health they focused on illness or injury, treatment of disease or other …

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