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    • All HBS Web  (210)
      • Faculty Publications  (26)

      Food And Drug Administration Remove Food And Drug Administration →

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      Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
      Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
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      • January–February 2021
      • Article

      Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

      By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
      As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...  View Details
      Keywords: Medical Devices; Fda; Health Care And Treatment; Government administration; Information; Standards
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      Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
      • November 2020
      • Teaching Note

      Valuing Celgene's CVR

      By: Benjamin C. Esty and Daniel Fisher
      When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...  View Details
      Keywords: Mergers And Acquisitions; Valuation; Value; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition And Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Teaching Note 221-036, November 2020.
      • November 2020
      • Case

      Valuing Celgene's CVR

      By: Benjamin C. Esty and Daniel Fisher
      When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...  View Details
      Keywords: Mergers And Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition And Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Case 221-031, November 2020.
      • November 2020
      • Supplement

      Valuing Celgene's CVR

      By: Benjamin C. Esty and Daniel Fisher
      When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...  View Details
      Keywords: Mergers And Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition And Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Spreadsheet Supplement 221-705, November 2020.
      • October 2020
      • Case

      COVID-19 Testing at Everlywell

      By: Jeffrey J. Bussgang and Olivia Hull
      In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the...  View Details
      Keywords: Entrepreneurship; Business Strategy; Venture Capital; Health Care And Treatment; Health Disorders; Leading Change; Technology Adoption; Technology Platform; Competitive Strategy; Science; Adaptation; Corporate Social Responsibility And Impact; Crisis Management; Social Entrepreneurship; Ethics; Government Legislation; Health; Health Testing And Trials; Health Pandemics; Consumer Products Industry; Health Industry; Technology Industry; Texas; United States
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      Bussgang, Jeffrey J., and Olivia Hull. "COVID-19 Testing at Everlywell." Harvard Business School Case 821-001, October 2020.
      • 2020
      • Working Paper

      Chimeric Antigen Receptor (CAR) T-Cell Therapy: Case Histories of Significant Medical Advances

      By: Amar Bhidé and Srikant M. Datar
      In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works; 2) the foundational advances and discoveries; 3)...  View Details
      Keywords: Immunotherapy; Health Care And Treatment; Innovation And Invention; Research And Development; Governing Rules, Regulations, And Reforms
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      Bhidé, Amar, and Srikant M. Datar. "Chimeric Antigen Receptor (CAR) T-Cell Therapy: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-034, August 2020.
      • Article

      Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study

      By: Noy Alon, Ariel Dora Stern and John Torous
      BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...  View Details
      Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care And Treatment; Mobile Technology; Software
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      Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
      • April 2020
      • Article

      Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning

      By: Ariel Dora Stern and W Nicholson Price, II
      In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...  View Details
      Keywords: Machine Learning; Causal Inference; Health Care And Treatment; Safety; Governing Rules, Regulations, And Reforms
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      Stern, Ariel Dora, and W Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
      • January 2020
      • Article

      The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System

      By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
      Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...  View Details
      Keywords: Medical Devices; Health Testing And Trials; Analysis; Sales
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      Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
      • 2020
      • Working Paper

      Magnetic Resonance Imaging: Case Histories of Significant Medical Advances

      By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins
      We describe how and why Magnetic Resource Imaging (MRI) came to complement—and partially replace—computed tomography (CT) imaging of soft tissue. Specifically we chronicle: 1) the development of foundational techniques and prototypes (through the 1970s); 2) how U.S....  View Details
      Keywords: Health Care And Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation And Invention; Innovation And Invention; Governing Rules, Regulations, And Reforms
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      Datar, Srikant M., Amar Bhidé, and Katherine Stebbins. "Magnetic Resonance Imaging: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-001, July 2019. (Revised July 2020.)
      • Article

      Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

      By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
      Objectives:
      To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and...  View Details
      Keywords: Digital; Medicine; Fda; Cybersecurity; Health Care And Treatment; Software; Safety; Medical Devices And Supplies Industry
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      Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
      • February 2018
      • Article

      Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience

      By: Bradley R. Staats, Diwas S. KC and F. Gino
      Many models in operations management involve dynamic decision making that assumes optimal updating in response to information revelation. However, behavioral theory suggests that rather than updating their beliefs, individuals may persevere in their prior beliefs. In...  View Details
      Keywords: Information; Announcements; Service Operations; Decision Making; Medical Specialties; Experience And Expertise; Medical Devices And Supplies Industry
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      Staats, Bradley R., Diwas S. KC, and F. Gino. "Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience." Management Science 64, no. 2 (February 2018): 804–824.
      • January 2018
      • Article

      The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

      By: Aaron V. Kaplan and Ariel Dora Stern
      The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...  View Details
      Keywords: Health Testing And Trials; Business And Government Relations; Governing Rules, Regulations, And Reforms; Information Publishing; Medical Devices And Supplies Industry; United States
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      Kaplan, Aaron V., and Ariel Dora Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
      • November 2017
      • Case

      The 'Wonder Drug' That Killed Babies

      By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
      In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children...  View Details
      Keywords: Regulation; Business And Government Relations; Business And Community Relations; Business And Stakeholder Relations; Product Marketing; Corporate Social Responsibility And Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, And Reforms; Pharmaceutical Industry; Public administration Industry; United States; United Kingdom; Australia; Germany; Europe
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      Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
      • May 2016 (Revised March 2020)
      • Teaching Note

      Cyberdyne: A Leap to the Future

      By: Doug J. Chung and Mayuka Yamazaki
      Cyberdyne Inc. was a Japanese technology venture founded in 2004 by scientist Yoshiyuki Sankai to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from...  View Details
      Keywords: Health Disorders; Technological Innovation; Marketing Strategy; Decisions; Product Launch; Medical Devices And Supplies Industry
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      Chung, Doug J., and Mayuka Yamazaki. "Cyberdyne: A Leap to the Future." Harvard Business School Teaching Note 516-114, May 2016. (Revised March 2020.)
      • January 2016 (Revised July 2018)
      • Case

      Cyberdyne: A Leap to the Future

      By: Doug J. Chung and Mayuka Yamazaki
      Cyberdyne Inc. was a Japanese technology venture that wanted to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from stroke, spinal cord injury (SCI),...  View Details
      Keywords: Go-to-market Strategy; Pricing; Sales Channel; Technological Innovation; Marketing; Sales; Distribution; Strategy; Medical Devices And Supplies Industry
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      Chung, Doug J., and Mayuka Yamazaki. "Cyberdyne: A Leap to the Future." Harvard Business School Case 516-072, January 2016. (Revised July 2018.)
      • 2015
      • Working Paper

      Blinded by Experience: Prior Experience, Negative News and Belief Updating

      By: Bradley R. Staats, Diwas S. KC and Francesca Gino
      Traditional models of operations management involve dynamic decision-making assuming optimal (Bayesian) updating. However, behavioral theory suggests that individuals exhibit bias in their beliefs and decisions. We conduct both a field study and two laboratory studies...  View Details
      Keywords: Behavioral Operations; Egocentric Bias; Experience; Healthcare Operations; Prejudice And Bias; Behavior; Operations; Decision Making; Health Care And Treatment
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      Staats, Bradley R., Diwas S. KC, and Francesca Gino. "Blinded by Experience: Prior Experience, Negative News and Belief Updating." Harvard Business School Working Paper, No. 16-015, August 2015.
      • January 2014 (Revised June 2014)
      • Case

      23andMe: Genetic Testing for Consumers (A)

      By: John A. Quelch and Margaret L. Rodriguez
      On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was...  View Details
      Keywords: Marketing; Public Health; Strategy; Genome Testing; Health Care; Genetics; Ancestry; 23andme; Marketing; Product Launch; Health; Health Care And Treatment; Health Testing And Trials; Genetics; Strategy; Health Industry; United States
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      Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
      • November 2010
      • Supplement

      Hikma Pharmaceuticals (B)

      By: John A. Quelch
      By 2009, Hikma Pharmaceuticals operated 13 manufacturing plants in 8 countries of which 5 were approved by the U.S. Food and Drug Administration. Hikma tracked its sales revenues over the period to show where the largest contributors were from.  View Details
      Keywords: Strategy; Knowledge Use And Leverage; Sales; Pharmaceutical Industry
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      Quelch, John A. "Hikma Pharmaceuticals (B)." Harvard Business School Supplement 511-075, November 2010.
      • November 2009 (Revised March 2013)
      • Case

      PureCircle

      By: David E. Bell and Aldo Sesia
      In December 2008, the U.S. Food and Drug Administration (FDA) determined that high-purity Rebaudioside A (Reb A), a natural and calorie-free product that a young company named PureCircle manufactured from the Stevia plant, could be used in beverages, foods, and as a...  View Details
      Keywords: Customer Relationship Management; Investment; Globalization; Leadership; Risk Management; Product Launch; Production; Performance Productivity; Business And Shareholder Relations; food And Beverage Industry; United States
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      Bell, David E., and Aldo Sesia. "PureCircle." Harvard Business School Case 510-032, November 2009. (Revised March 2013.)
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      Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
      Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
      → Search All HBS Web
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