According to the National Organization for Rare Disorders
(NORD), a disease is rare if it affects fewer than 200,000 Americans.
Big Pharma used to ignore this segment of the market, but now developing
orphan drugs to treat these rare diseases is an industry priority.
Driving efficient timelines is a key to bringing products to market on
an accelerated track. If you don’t have formulation, analytical,
clinical, and manufacturing resources and infrastructure in-house,
maintaining a development programs that takes full advantage of an
expedited designation from the FDA can be challenging.
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