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Where New Matter Actually Comes From: CIP Trigger Points in FDA Drug Development Why Preclinical Polymorphs and Phase I Formulation Data Drive Most Secondary Patent Filings The FDAs five-stage development pathway discovery, preclinical, Phase I, Phase II, Phase III and post-approval does not generate patentable new matter at uniform rates
The agency also posted a warning letter it sent to an online pharmacy website for the illegal sale of non-FDA-approved prescription opioids, benzodiazepines, and amphetamines
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