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- All HBS Web (166)
- Faculty Publications (66)
- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
and effective in preventing severe disease, and their accelerated review will go down in history as having saved millions of lives. But COVID vaccines weren’t the first medical products to be brought to market through an expedited process. So how do other new therapies... View Details
- 01 Sep 2023
- News
Money Does Grow on (Family) Trees
time each test cost $999; today the company charges one-tenth that—$99—for its ancestry-focused testing. In its earliest days, 23andMe targeted both the health-conscious consumer and those interested in ancestry, but when it faced temporary challenges from the View Details
- 30 Jun 2022
- HBS Case
Peloton Changed the Exercise Game. Can the Company Push Through the Pain?
got a lot of levers to pull.” Despite the risk, Dolan believes Peloton does appear to have a future. “It’s not like they’re a high-tech company, wondering if a drug will get FDA approval,” Dolan says. “No surprises are coming down the... View Details
- 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 and Wireless Technology; Applications and Software; Framework
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).
- Web
Academics - Health Care
fibrosis. A goal of the program is to draw out some key debates that are more broadly relevant to life sciences, such as: the value of early detection, the pricing of life saving drugs, the incentives for innovation, and the speed of FDA... View Details
- 22 Feb 2024
- News
Combat-Tested Cancer Coaching
Subscribe on iTunes Subscribe on Spotify More Skydeck episodes Hi, this is Dan Morrell, host of Skydeck. When Kathy Giusti (MBA 1985) was diagnosed with multiple myeloma in 1996, she was overwhelmed. It was the pre-Internet era, with limited available information, but... View Details
- 01 Mar 2024
- News
The War Within
When the full-scale Russian invasion of Ukraine began in February 2022, Nataliia Zhyliak’s world was upended in a matter of days. At the time, Zhyliak, a psychologist in the western Ukrainian city of Kamianets-Podilskyi, was working at an education and rehabilitation... View Details
- 30 Jun 2014
- Lessons from the Classroom
The Role of Emotions in Effective Negotiations
A Happier Ending In an "alternate ending" to the story, Kate apologizes for how the negotiation has gotten out of control, and asks if they can start over. She shares her own anxieties and frustrations about an important conference call regarding View Details
- Research Summary
Experience and description-based decision making.
Prof. Barron and his co-authors study the effect of the economic environment on decision making. One example involves the effect of rare (low probability) events. People behave as if they overweight these events in some settings (e.g., when buying insurance and... View Details
- Web
The 20th Century Zeitgeist - Leadership
soars GI Bill Influence: Medium-Low 50 1950 s 19 Social conformity McCarthyism Membership in organized religion soars Brown v. Board of Education desegregated public schools> Influence: Medium-High 60 1960 s 19 Civil rights movement gain strength Antiwar sentiment... View Details
- Web
Charts & Statistics - Leadership
Medium-High 60 1960 s 19 Civil rights movement gain strength Antiwar sentiment divides electorate FDA approves oral contraceptive pill Influence: High 70 1970 s 19 National Organization for Women mobilizes for Equal Rights Amendment Roe... View Details
- Web
Rare Disease Day – Small Numbers, Big Challenges… and Big Opportunities - Blog: Health Supplement
disorder immediately. HHT has no cure or FDA approved treatment yet, and severe complications can arise if it is not properly diagnosed or treated. People living with rare diseases, like HHT, suffer from increased mortality and reduced... View Details
- 12 Jun 2018
- Research & Ideas
In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?
creating, at great time and cost, a successful therapy, and then beating long odds to win FDA approval, the rewards can wane as quickly as a patent expires. And most drug candidates wash out long before even making it to market. That... View Details
- 31 Jan 2014
- News
Body, Heal Thyself
the challenges?'" The answer to that question was Peter Barton Hutt, former chief counsel for the FDA and an expert on food and drug law, so they recruited him to join the board. Moderna is now winning over some very big supporters. In... View Details
- 01 Dec 2007
- News
Faculty Books
Perspectives on Risk and Regulation: The FDA at 100 edited by Arthur Daemmrich and Joanna Radin (Chemical Heritage Foundation) In a period of rapid scientific and market changes, success in regulating food products, prescription drugs,... View Details
Donald H. Rumsfeld
profit of over $120 million in 1982. The real success of Searle under Rumsfeld, however, came with the FDA approval of Aspartame, the artificial sweetener that became popular and very profitable for Searle during the 1980s diet craze. View Details
Keywords: Healthcare
- Fast Answer
Medical Devices: Pipeline
agencies, and private industry. Studies listed in the database are conducted in 50 states and 157 countries. US FDA Medical Device Databases – provides a list of over 20 specific databases covering guidance, pre-market approval,... View Details
- 09 Apr 2012
- Research & Ideas
Who Sways the USDA on GMO Approvals?
Other Agencies Influence Approvals In the case of procedural legitimacy, the researchers found a strong influence from an unlikely source—the USDA's sister agency, the Food and Drug Administration. In the process of approving GMOs, companies have the option of... View Details
- 09 Apr 2019
- News
Finding a Fix for Food Allergies
photo by Stu Rosner Food allergies affect 30 million Americans and one in 12 children, sometimes triggering life-threatening reactions. Yet there are no approved FDA treatments or cures. These sobering facts became alarmingly real to... View Details
Keywords: Jill Radsken
- 21 Aug 2007
- First Look
First Look: August 21, 2007
http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=807074 PublicationsPerspectives on Risk and Regulation: The FDA at 100 Author:Arthur A. Daemmrich Publication:Chemical Heritage Press, 2007 Abstract Perspectives on Risk and... View Details
Keywords: Martha Lagace