Patents and Exclusivity Flashcards

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0
Q

Leahy-Smith America Invents Act of 2011

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1
Q

Uruguay Rounds agreements Act of 1994

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2
Q

Generating Antibiotics Incentives Now Act (GAIN Act)

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3
Q

Food and Drug Administration Safety and novation Act (FDASIA) Section VIII

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4
Q

Humane Use Device provisions

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FDASIA Title VI, Part L

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5
Q

PDUFA V, FDASIA Title I

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6
Q

21 CFR 314 Bioavailability and Bioquivalence Requirements

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7
Q

21 CFR 316

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Orphan Drugs

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