fda logo overview

The original intention of FDA “special status” programs such as “orphan status” and “breakthrough therapy” was to level the playing field by providing financial and development incentives to get drug companies to target ailments or treatment types which would otherwise be ignored. And these programs have certainly achieved that goal of motivating the pharma industry….

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fda logo overview

Drug development companies often issue press releases touting that their drug has received special designations from the FDA citing terms such as “orphan” drug status, “fast track” approval and “breakthrough therapy”. These announcements often cause share prices to spike to an extent which is not justified by the substance of such designations. These so-called “special”…

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