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14 in total

1. Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.

Authors: Huseyin Naci; Olivier J Wouters; Radhika Gupta; John P A Ioannidis
Journal: Milbank Q Date: 2017-06 Impact factor: 4.911

2. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.

Authors: Huseyin Naci; Katelyn R Smalley; Aaron S Kesselheim
Journal: JAMA Date: 2017-08-15 Impact factor: 56.272

3. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018.

Authors: Olivier J Wouters; Martin McKee; Jeroen Luyten
Journal: JAMA Date: 2020-03-03 Impact factor: 157.335

4. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage.

Authors: Aaron S Kesselheim; Carolyn L Treasure; Steven Joffe
Journal: PLoS Med Date: 2017-01-03 Impact factor: 11.069

5. An appraisal of drug development timelines in the Era of precision oncology.

Authors: Denis Leonardo Jardim; Maria Schwaederle; David S Hong; Razelle Kurzrock
Journal: Oncotarget Date: 2016-08-16

6. The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs.

Authors: Aviv Ladanie; Benjamin Speich; Florian Naudet; Arnav Agarwal; Tiago V Pereira; Francesco Sclafani; Juan Martin-Liberal; Thomas Schmid; Hannah Ewald; John P A Ioannidis; Heiner C Bucher; Benjamin Kasenda; Lars G Hemkens
Journal: Trials Date: 2018-09-19 Impact factor: 2.279

10. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.

Authors: Sana R Mostaghim; Joshua J Gagne; Aaron S Kesselheim
Journal: BMJ Date: 2017-09-07

Drug development and FDA approval, 1938-2013.