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In this section: Public Health Strategy and Analysis Staff

PHSA Research & Publications

PHSA conducts and publishes peer-reviewed research on topics of importance to FDA.

PHSA Research and Publications

Year

Topic

Year	Publication	Topic
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

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