1. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals. (August 2015) Authors: Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena Journal: Expert review of molecular diagnostics Issue: Volume 15:Number 7(2015) Page Start: 869 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Development, Validation, and Regulatory Considerations for a Liquid Biopsy Test. (24th February 2020) Authors: Tsui, Dana W Y; Blumenthal, Gideon M; Philip, Reena; Barrett, J Carl; Montagut, Clara; Bramlett, Kelli; Ladanyi, Marc; Ghosh, Soma Journal: Clinical chemistry Issue: Volume 66:Number 3(2020) Page Start: 408 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. Issue 11 (10th April 2022) Authors: Royce, Melanie; Osgood, Christy; Mulkey, Flora; Bloomquist, Erik; Pierce, William F.; Roy, Arpita; Kalavar, Shyam; Ghosh, Soma; Philip, Reena; Rizvi, Fatima; Mixter, Bronwyn D.; Tang, Shenghui; Pazdur, Richard; Beaver, Julia A.; Amiri-Kordestani, Laleh Journal: Journal of clinical oncology Issue: Volume 40:Issue 11(2022) Page Start: 1155 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations. (7th February 2018) Authors: Odogwu, Lauretta; Mathieu, Luckson; Blumenthal, Gideon; Larkins, Erin; Goldberg, Kirsten B.; Griffin, Norma; Bijwaard, Karen; Lee, Eunice Y.; Philip, Reena; Jiang, Xiaoping; Rodriguez, Lisa; McKee, Amy E.; Keegan, Patricia; Pazdur, Richard Journal: Oncologist Issue: Volume 23:Number 6(2018) Page Start: 740 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer. (20th October 2020) Authors: Arora, Shaily; Balasubramaniam, Sanjeeve; Zhang, Hui; Berman, Tara; Narayan, Preeti; Suzman, Daniel; Bloomquist, Erik; Tang, Shenghui; Gong, Yutao; Sridhara, Rajeshwari; Turcu, Francisca Reyes; Chatterjee, Deb; Saritas‐Yildirim, Banu; Ghosh, Soma; Philip, Reena; Pathak, Anand; Gao, Jennifer J.; A... Journal: Oncologist Issue: Volume 26:Number 1(2021) Page Start: e164 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA‐Mutated Metastatic Castrate‐Resistant Prostate Cancer. (17th November 2020) Authors: Anscher, Mitchell S.; Chang, Elaine; Gao, Xin; Gong, Yutao; Weinstock, Chana; Bloomquist, Erik; Adeniyi, Oluseyi; Charlab, Rosane; Zimmerman, Sarah; Serlemitsos‐Day, Maritsa; Ning, Yang Min; Mayrosh, Ruth; Fuller, Barbara; Trentacosti, Ann Marie; Gallagher, Pamela; Bijwaard, Karen; Philip, Reena;... Journal: Oncologist Issue: Volume 26:Number 2(2021) Page Start: 139 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. (14th December 2017) Authors: Odogwu, Lauretta; Mathieu, Luckson; Goldberg, Kirsten B.; Blumenthal, Gideon M.; Larkins, Erin; Fiero, Mallorie H.; Rodriguez, Lisa; Bijwaard, Karen; Lee, Eunice Y.; Philip, Reena; Fan, Ingrid; Donoghue, Martha; Keegan, Patricia; McKee, Amy; Pazdur, Richard Journal: Oncologist Issue: Volume 23:Number 3(2018) Page Start: 353 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases. Issue 4 (4th February 2020) Authors: Febbo, Phillip G.; Martin, Anne‐Marie; Scher, Howard I.; Barrett, J. Carl; Beaver, Julia A.; Beresford, Paul J.; Blumenthal, Gideon M.; Bramlett, Kelli; Compton, Carolyn; Dittamore, Ryan; Eberhard, David A.; Edelstein, Daniel; Godsey, James; Gruen, Andrew; Hanlon, Sean E.; Hicks, James; Hovelson,... Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 4(2020) Page Start: 730 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Multivariate Analysis to Predict the Horizontal Anterior Chamber Diameter from Other Anterior Chamber Parameters Using Scheimpflug Imaging: Is There a Better Method Than Adding a Fixed Constant?. (2nd January 2017) Authors: Prakash, Gaurav; Philip, Reena; Bacero, Ruthchel; Srivastava, Dhruv Journal: Current eye research Issue: Volume 42:Number 1(2017) Page Start: 58 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. Regulatory implications of ctDNA in immuno-oncology for solid tumors. Issue 2 (16th February 2023) Authors: Vellanki, Paz J; Ghosh, Soma; Pathak, Anand; Fusco, Michael J; Bloomquist, Erik W; Tang, Shenghui; Singh, Harpreet; Philip, Reena; Pazdur, Richard; Beaver, Julia A Journal: Journal for immunotherapy of cancer Issue: Volume 11:Issue 2(2023) Page Start: Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗