1. A Vision for Therapeutic Innovation & Regulatory Science. (March 2019) Authors: Daniel, Gregory Journal: Therapeutic innovation & regulatory science Issue: Volume 53:Number 2(2019:Mar.) Page Start: 169 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Building a drug development database: challenges in reliable data availability. (2nd January 2017) Authors: Audibert, Céline; Romine, Morgan; Caze, Alexis; Daniel, Gregory; Leff, Jonathan; McClellan, Mark Journal: Drug development and industrial pharmacy Issue: Volume 43:Number 1(2017) Page Start: 74 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Building Trust in RWE Will Support Clearer Regulatory Uses. (July 2019) Authors: Daniel, Gregory Journal: Therapeutic innovation & regulatory science Issue: Volume 53:Number 4(2019:Jul.) Page Start: 417 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodologic, and Operational Considerations. (January 2019) Authors: Richardson, Elizabeth; Burnell, Jessica; Adams, Heather R.; Bohannon, Richard W.; Bush, Elizabeth Nicole; Campbell, Michelle; Chen, Wen Hung; Coons, Stephen Joel; Papadopoulos, Elektra; Reeve, Bryce R.; Rooks, Daniel; Daniel, Gregory Journal: Therapeutic innovation & regulatory science Issue: Volume 53:Number 1(2019:Jan.) Page Start: 146 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools. Issue 3 (2nd February 2018) Authors: Sobel, Rachel E.; Bate, Andrew; Marshall, James; Haynes, Kevin; Selvam, Nandini; Nair, Vinit; Daniel, Gregory; Brown, Jeffrey S.; Reynolds, Robert F. Journal: Pharmacoepidemiology and drug safety Issue: Volume 27:Issue 3(2018) Page Start: 332 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Improving transparency to build trust in real‐world secondary data studies for hypothesis testing—Why, what, and how: recommendations and a road map from the real‐world evidence transparency initiative. Issue 11 (13th September 2020) Authors: Orsini, Lucinda S.; Monz, Brigitta; Mullins, C. Daniel; Van Brunt, David; Daniel, Gregory; Eichler, Hans‐Georg; Graff, Jennifer; Guerino, John; Berger, Marc; Lederer, Nirosha M.; Jonsson, Pall; Schneeweiss, Sebastian; Wang, Shirley V.; Crown, William; Goettsch, Wim; Willke, Richard J. Journal: Pharmacoepidemiology and drug safety Issue: Volume 29:Issue 11(2020) Page Start: 1504 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?. (November 2018) Authors: Richardson, Elizabeth; Daniel, Gregory; Joy, David R.; Kweder, Sandra L.; Maloney, Diane M.; Raggio, Miranda J.; Jarow, Jonathan P. Journal: Therapeutic innovation & regulatory science Issue: Volume 52:Number 6(2018:Nov.) Page Start: 793 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗