2023 |
Authorized Generics in the US: Prevalence, Characteristics and Timing, 2010-19
Health Affairs
Fowler, A., Jacobo-Rubio, R., & Xu, J. |
Regulatory Process and Transparency |
2022 |
Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021
JAMA Network Open
Monge, A., Sigelman, S., Temple, R., & Chahal, H. |
Regulatory Process and Transparency |
2021 |
Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity
JAMA
Chahal, H.S., Fowler, A.C., Patel, R., & Shimer, M. |
Regulatory Process and Transparency |
2021 |
Marketing of First Generic Drugs Approved by U.S. FDA from January 2010 to June 2017
U.S. Food and Drug Administration
Chahal, H.S., Patel, R., & Shimer, M. |
Regulatory Process and Transparency |
2021 |
Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey BioDrugs
Kolbe, A.R., Kearsley, A., Merchant, L., Temkin, E., Patel, A., Xu, J., & Jessup, A. |
Drugs and Biologics |
2021 |
Impact of the US Food and Drug Administration Registration of Antiretroviral Drugs on Global Access to HIV Treatment BMJ Global Health
Chahal, H., Capella, P., Presto, R., Murray, J., Shimer, M., Valdez, M., & Lurie, P. |
Regulatory Process and Transparency |
2019 |
Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants JAMA Internal Medicine
Chahal, H., Mukherjee, S., Sigelman, D., & Temple, R. |
Global Health |
2019 |
State naloxone access laws are associated with an increase in the number of naloxone prescriptions dispensed in retail pharmacies Drug and Alcohol Dependence
Xu, J., Davis, C. S., Cruz, M., & Lurie, P. |
Regulatory Process and Transparency |
2018 |
An Evaluation of US Food and Drug Administration’s Program to Register HIV Drugs for Use in Resource-Constrained Settings JAMA Network Open
Chahal, H., Koukounas, K., Capella, P., Presto, R., Murray, J., Shimer, M., Riley, K., & Valdez, M. |
Global Health |
2018 |
Hepatitis B surface antigen testing among pregnant women, United States 2014 The Pediatric Infectious Disease Journal
Kolasa, M., Tsai, Y., Xu, J., Fenlon, N., & Schillie, S. |
Opioids |
2018 |
State Continuing Education Requirements for Physicians and Dentists, Including Requirements Related to Pain Management and Controlled Substance Prescribing Journal of Medical Regulation
Xu, J., Gribble, A., Sigelman, D., Powell, C., & Lurie, P. |
Opioids |
2017 |
Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications with the US Food and Drug Administration JAMA Internal Medicine
Chahal, H., Szeto, D., Chaudhry, A., Sigelman, D., Kim, S., & Lurie, P. |
Global Health |
2017 |
New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 through 2015 Anesthesiology: The Journal of the American Society of Anesthesiologists
Chai, G., Xu, J., Osterhout, J., Liberatore, M. A., Miller, K. L., Wolff, C., Cruz, M., Lurie, P., & Dal Pan, G. |
Regulatory Process and Transparency |
2017 |
The US Food and Drug Administration's Tentative Approval Process and the Global Fight against HIV Journal of the International AIDS Society
Chahal, H., Murray, J., Shimer, M., Capella, P., Presto, R., Valdez, M. & Lurie, P. |
Regulatory Process and Transparency |
2017 |
Association of appearance of conflicts of interest with voting behavior at FDA advisory committee meetings—a cross-sectional study JAMA Internal Medicine
Xu, J., Emenanjo, O., Ortwerth, M., & Lurie, P. |
Policy and Program Evaluation |
2017 |
Effect of US Food and Drug Administration–Approved Pediatric Labeling on Dispensing of Extended Release Oxycodone in the Outpatient Retail Setting JAMA pediatrics
Xu, J., Gill, R., Cruz, M., Staffa, J., & Lurie, P. |
Opioids |
2016 |
Comparison of Content of FDA Letters Not Approving Applications for New Drugs and Associated Public Announcements from Sponsors: Cross Sectional Study BMJ
Lurie, P., Chahal, H., Sigelman, D., Stacy, S., Sclar, J., & Ddamulira, B. |
Opioids |
2015 |
Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013 JAMA Internal Medicine
Cruz, M., Xu, J., Kashoki, M., & Lurie, P. |
Regulatory Process and Transparency |