| An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987–2011 M Lanthier, KL Miller, C Nardinelli, J Woodcock Health Affairs 32 (8), 1433-1439, 2013 | 139 | 2013 |
| Investigating the landscape of US orphan product approvals KL Miller, M Lanthier Orphanet journal of rare diseases 13, 1-8, 2018 | 71 | 2018 |
| Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare oncologic … KL Miller, LJ Fermaglich, J Maynard Orphanet journal of rare diseases 16 (1), 265, 2021 | 66 | 2021 |
| Regulatory watch: Innovation in biologic new molecular entities: 1986-2014. KL Miller, M Lanthier Nature reviews Drug discovery 14 (2), 2015 | 55 | 2015 |
| Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals A Schick, KL Miller, M Lanthier, G Dal Pan, C Nardinelli Drug Safety, 2017 | 39 | 2017 |
| A comprehensive study of the rare diseases and conditions targeted by orphan drug designations and approvals over the forty years of the Orphan Drug Act LJ Fermaglich, KL Miller Orphanet Journal of Rare Diseases 18 (1), 163, 2023 | 35 | 2023 |
| Trends In Orphan New Molecular Entities, 1983–2014: Half Were First In Class, And Rare Cancers Were The Most Frequent Target KL Miller, M Lanthier Health Affairs 35 (3), 464-470, 2016 | 33 | 2016 |
| Do investors value the FDA orphan drug designation? KL Miller Orphanet Journal of Rare Diseases 12, 1-6, 2017 | 31 | 2017 |
| Is the priority review voucher program stimulating new drug development for tropical diseases? KW Kerr, TC Henry, KL Miller PLoS neglected tropical diseases 12 (8), e0006695, 2018 | 22 | 2018 |
| New opioid analgesic approvals and outpatient utilization of opioid analgesics in the United States, 1997 through 2015 G Chai, J Xu, J Osterhout, MA Liberatore, KL Miller, C Wolff, M Cruz, ... Anesthesiology 128 (5), 953-966, 2018 | 15 | 2018 |
| Drugs and biologics receiving FDA orphan drug designation: an analysis of the most frequently designated products and their repositioning strategies KL Miller, S Kraft, A Ipe, L Fermaglich Expert Opinion on Orphan Drugs 9 (11-12), 265-272, 2021 | 14 | 2021 |
| FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product development KL Miller, C Mueller, G Liu, KI Miller Needleman, J Maynard Orphanet Journal of Rare Diseases 15, 1-8, 2020 | 10 | 2020 |
| Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation A Chandra, J Kao, KL Miller, AD Stern Review of Economics and Statistics, 1-46, 2024 | 9 | 2024 |
| An Analysis of Follow‐On Development in New Drug Classes, January 1986–June 2018 ML Lanthier, KW Kerr, KL Miller Clinical Pharmacology & Therapeutics 106 (5), 1125-1132, 2019 | 9 | 2019 |
| Value Assessment in the Regulatory Context KL Miller, J Woodcock Value in Health 20 (2), 296-8, 2017 | 8 | 2017 |
| The Signaling Effects of the US Food and Drug Administration Fast‐Track Designation KL Miller, C Nardinelli, G Pink, K Reiter Managerial and Decision Economics 38 (4), 581-594, 2017 | 5 | 2017 |
| Orphan Drug Label Expansions: Analysis Of Subsequent Rare And Common Indication Approvals: Article examines secondary orphan drug indications KL Miller, M Lanthier Health Affairs 43 (1), 18-26, 2024 | 3 | 2024 |
| The effect of the COVID-19 pandemic on US Food and Drug Administration funded clinical trials and natural history studies for rare diseases KL Miller, KIM Needleman Contemporary Clinical Trials 129, 107198, 2023 | 3 | 2023 |
| Determining Commonalities in the Experiences of Patients with Rare Diseases: A Qualitative Analysis of US Food and Drug Administration Patient Engagement Sessions C Mease, LJ Fermaglich, K Jackler, S Shermer, KL Miller The Patient-Patient-Centered Outcomes Research 17 (1), 25-37, 2024 | 2 | 2024 |
| Transition probabilities for clinical trials: investigating individual diseases KL Miller, D Rabinovitz, KW Kerr Nature Reviews: Drug Discovery, 2019 | 2 | 2019 |
Lewis FermaglichU.S. Food and Drug Administration在 fda.hhs.gov 的电子邮件经过验证
