Filter Results
:
(170)
Show Results For
- All HBS Web (170)
- Faculty Publications (64)
Show Results For
- All HBS Web (170)
- Faculty Publications (64)
- 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
- 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
- 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
Faculty & Advisors - MBA
Ramaswami is Head of Product at Sidewalk Labs where he focuses on using digital technology to radically improve the quality of urban life. Previously, Prem served as a Product Lead on Google Search’s Social Impact verticals including launching Health Search and helping...
View Details
- 22 Feb 2024
- News
Combat-Tested Cancer Coaching
part is it's moving fast, and it's moving faster than it ever has before. So this year alone, FDA approved 45 oncology drugs. Now, how are we supposed to know what's going on in our own specific cancers? And on average, our doctors Give...
View Details
- Web
Pharmaceuticals | Baker Library | Bloomberg Center | Harvard Business School
country. U.S. FDA: Drug: Guidance, Compliance, & Regulatory Information /citations/u.s.-fda-drug-guidance-compliance-regulatory-information U.S. FDA website provides the latest U.S. drug regulatory information. 55 1159 U.S. FDA: Drug:...
View Details
- Web
Biotechnology | Baker Library | Bloomberg Center | Harvard Business School
startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. Check Harvard Availability FDA Biotechnology Guidance /citations/fda-biotechnology-guidance 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
- 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
- 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
- Web
The 20th Century Zeitgeist - Leadership
McCarthyism Membership in organized religion soars Brown v. Board of Education desegregated public schools> Influence: Medium-High 601960s19 Civil rights movement gain strength Antiwar sentiment divides electorate FDA approves oral...
View Details
- Web
Medical Devices | Baker Library | Bloomberg Center | Harvard Business School
Databases /citations/fda-medical-devices-databases Databases from FDA covering guidance, pre-market approval, notification 501(k)s, registrations, and listings. Most of the databases are updated weekly or monthly. 55 1714 FDA: Medical...
View Details
- Web
Building Collections | Baker Library | Bloomberg Center | Harvard Business School
monograph cover, 1998. Henri Termeer papers.In 1991, the FDA approved the first treatment for Gaucher disease, a rare genetic disease. Genzyme’s drug, Ceredase, reversed symptoms and halted the disease for patients who had suffered for...
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
Rare Disease Day – Small Numbers, Big Challenges… and Big Opportunities - Blog: Health Supplement
opinion and was referred to a specialist nearby at Yale New Haven Hospital. Fortunately, it just so happened that an Interventional Radiologist at Yale was the godfather of HHT back in the ‘90s. Upon seeing my mother, the physicians recognized the disorder immediately....
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
- Web
Charts & Statistics - Leadership
electorate FDA approves oral contraceptive pill Influence: High 701970s19 National Organization for Women mobilizes for Equal Rights Amendment Roe v. Wade legalizes abortion Social discord continues over Vietnam War and civil rights...
View Details
- 14 Dec 2020
- Research & Ideas
What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?
aspects of the drug trial and approval process, including allowing time for potential issues to materialize. When you see an FDA emergency approval for a COVID-19 vaccine, don't interpret this as a normal “FDA approval.” I understand that...
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