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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. However, 505(b)(2) drugs have been available since the 1980s. “CMS

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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements. Published February 2003. Published February 2003.

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Amarin Makes Moves towards Global Expansion of Vazkepa

Pharmaceutical Technology

The pharmaceutical company is well on its way to achieving its goals with successful full reimbursements, already confirmed in the United Kingdom ( UK), and Sweden. AstraZeneca ’s cholesterol drug Crestor (rosuvastatin) was approved in 2003 in the US but only approved in Germany in 2008. at a wholesale price within the US.