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California Proposition 65: Your Right to Know and More!

If you are a resident of California, or a visitor to the Golden State, you may have encountered the following warning: “This product contains chemicals known to the State of California to cause cancer, birth defects or other reproductive harm.”  This warning is intended to inform individuals of potential harmful exposures they otherwise may not …

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Planning to File Your 505(b)(2) Product in Canada?

Canada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size …

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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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