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1. Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Authors: Rachel E Sherman; Kathleen M Davies; Melissa A Robb; Nina L Hunter; Robert M Califf
Journal: Nat Rev Drug Discov Date: 2017-02-24 Impact factor: 84.694

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3 in total

Review 1. Challenges and opportunities to include patient-centric product design in industrial medicines development to improve therapeutic goals.

Authors: Carsten Timpe; Sven Stegemann; Andrew Barrett; Siddharthya Mujumdar
Journal: Br J Clin Pharmacol Date: 2020-06-16 Impact factor: 4.335

2. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.

Authors: Kerstin Noëlle Vokinger; Aaron S Kesselheim
Journal: BMJ Open Date: 2019-10-10 Impact factor: 2.692

Review 3. The biosimilars journey: current status and ongoing challenges.

Authors: Igor Age Kos; Valderílio Feijó Azevedo; Daniel Egg Neto; Sérgio Cândido Kowalski
Journal: Drugs Context Date: 2018-10-01

3 in total