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10 in total

1. The Prescription Drug User Fee Act: Much More Than User Fees.

Authors: Aaron P Mitchell; Niti U Trivedi; Peter B Bach
Journal: Med Care Date: 2022-04-01 Impact factor: 2.983

2. Expedited approval of cancer drugs without randomized controlled trials: Too good to be true?

Authors: Daniel Shepshelovich; Eitan Amir
Journal: Oncotarget Date: 2018-07-24

3. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.

Authors: Sarah Goring; Aliki Taylor; Kerstin Müller; Tina Jun Jian Li; Ellen E Korol; Adrian R Levy; Nick Freemantle
Journal: BMJ Open Date: 2019-02-27 Impact factor: 2.692

4. Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.

Authors: Matthew Herder
Journal: Milbank Q Date: 2019-08-12 Impact factor: 4.911

5. Efficacy gap between phase II and subsequent phase III studies in oncology.

Authors: Rick A Vreman; Svetlana V Belitser; Ana T M Mota; Anke M Hövels; Wim G Goettsch; Kit C B Roes; Hubert G M Leufkens; Aukje K Mantel-Teeuwisse
Journal: Br J Clin Pharmacol Date: 2020-02-21 Impact factor: 4.335

6. Criteria to Assess Independence in Continuing Medical Education (CME): Independence through Competence and Transparency.

Authors: Hans-Albert Gehle; Henrik Herrmann
Journal: J Eur CME Date: 2020-09-04

7. Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland.

Authors: Daniel Tobias Michaeli; Mackenzie Mills; Panos Kanavos
Journal: Appl Health Econ Health Policy Date: 2022-07-11 Impact factor: 3.686

8. Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.

Authors: Rick A Vreman; Huseyin Naci; Wim G Goettsch; Aukje K Mantel-Teeuwisse; Sebastian G Schneeweiss; Hubert G M Leufkens; Aaron S Kesselheim
Journal: Clin Pharmacol Ther Date: 2020-04-20 Impact factor: 6.875

9. Commentary: Expedited Regulatory Review of Low-Value Drugs.

Authors: Jonathan J Darrow; Reed F Beall
Journal: Healthc Policy Date: 2020-05

10. Improving the odds of drug development success through human genomics: modelling study.

Authors: Aroon D Hingorani; Valerie Kuan; Chris Finan; Felix A Kruger; Anna Gaulton; Sandesh Chopade; Reecha Sofat; Raymond J MacAllister; John P Overington; Harry Hemingway; Spiros Denaxas; David Prieto; Juan Pablo Casas
Journal: Sci Rep Date: 2019-12-11 Impact factor: 4.379

10 in total