Nasprx - Study guides, Class notes & Summaries

Patents for new medicine in US - 50% Patents for new medicine in Europe - 26% Patents for new medicine in Japan - 10.3% Patents for new medicine in South Korea, Taiwan, and India - 2.7% Patents for new medicine in China - 0.4% Patents for new medicine in other countries - 7% Research and Development - The "engine of innovation" focused on discovering or inventing new chemicals or molecules and turning them into safe Pharm products. Manufacturing & operations - Supply chain, manufacturi...

Exclusivity gives exclusive , is granted by the FDA, and can run concurrently with a patent or not. What differentiates exclusivity from a patent? What is required of an invention for it to be worthy of patent protection? A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality. Which of the following is NOT required by the FDA’s Criteria for Equivalency? A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality. What...