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Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

Deuterated Drugs Are New Chemical Entities

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

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