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Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman Reply.
- Published in:
- Hastings Center Report, 2024, v. 54, n. 2, p. 44, doi. 10.1002/hast.1579
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- Publication type:
- Article
CRISPR-phage antibacterials to address the antibiotic resistance crisis: scientific, economic, and regulatory considerations.
- Published in:
- Journal of Law & the Biosciences, 2024, v. 11, n. 1, p. 1, doi. 10.1093/jlb/lsad030
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- Publication type:
- Article
Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process.
- Published in:
- Journal of Health Politics, Policy & Law, 2023, v. 48, n. 5, p. 799, doi. 10.1215/03616878-10637726
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- Publication type:
- Article
Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.
- Published in:
- Hastings Center Report, 2023, v. 53, p. S60, doi. 10.1002/hast.1525
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- Publication type:
- Article
Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 114, n. 3, p. 614, doi. 10.1002/cpt.2954
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- Publication type:
- Article
EVIDENCE FOR COMMUNITY FACE MASKING TO LIMIT THE SPREAD OF SARS-COV-2: A CRITICAL REVIEW.
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- Health Matrix: Journal of Law-Medicine, 2023, v. 33, p. 1
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- Publication type:
- Article
Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings.
- Published in:
- 2023
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- Publication type:
- journal article
Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.
- Published in:
- JGIM: Journal of General Internal Medicine, 2022, v. 37, n. 16, p. 4176, doi. 10.1007/s11606-021-07316-0
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- Publication type:
- Article
Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review.
- Published in:
- Journal of Health Politics, Policy & Law, 2022, v. 47, n. 6, p. 649, doi. 10.1215/03616878-10041093
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- Publication type:
- Article
Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.
- Published in:
- 2022
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- Publication type:
- journal article
Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities.
- Published in:
- American Journal of Public Health, 2022, v. 112, n. 8, p. 1110, doi. 10.2105/ajph.2022.306888
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- Publication type:
- Article
Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 6, p. 1307, doi. 10.1002/cpt.2583
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- Publication type:
- Article
Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations.
- Published in:
- Frontiers in Pharmacology, 2022, v. 13, p. 1, doi. 10.3389/fphar.2022.913567
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- Publication type:
- Article
Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020.
- Published in:
- JAMA Network Open, 2022, v. 5, n. 5, p. e2212454, doi. 10.1001/jamanetworkopen.2022.12454
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- Publication type:
- Article
New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.
- Published in:
- Drug Safety, 2022, v. 45, n. 4, p. 305, doi. 10.1007/s40264-022-01152-9
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- Publication type:
- Article
Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes.
- Published in:
- Nature Biotechnology, 2022, v. 40, n. 2, p. 167, doi. 10.1038/s41587-021-01204-y
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- Publication type:
- Article
How Effective Are Cloth Face Masks? More than a century after the 1918 influenza pandemic, claims of the masks' effectiveness continue to lack a firm foundation.
- Published in:
- Regulation, 2021, v. 44, n. 4, p. 32
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- Publication type:
- Article
The Perils of Increasing Medicaid Rebates for Drugs With Accelerated Approval.
- Published in:
- JAMA Health Forum, 2021, v. 2, n. 10, p. 1, doi. 10.1001/jamahealthforum.2021.3184
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- Publication type:
- Article
Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed.
- Published in:
- Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 4, p. 1018, doi. 10.1002/cpt.2318
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- Publication type:
- Article
Changing FDA Approval Standards: Ethical Implications for Patient Consent.
- Published in:
- 2021
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- Publication type:
- Editorial
The timing of 30‐month stay expirations and generic entry: A cohort study of first generics, 2013–2020.
- Published in:
- CTS: Clinical & Translational Science, 2021, v. 14, n. 5, p. 1917, doi. 10.1111/cts.13046
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- Publication type:
- Article
RECONSIDERING ERADICATION TO ADDRESS THE GLOBAL INFECTIOUS DISEASE BURDEN.
- Published in:
- Quinnipiac Health Law Journal, 2021, v. 24, n. 3, p. 279
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- Publication type:
- Article
FDA Regulation and Approval of Medical Devices: 1976-2020.
- Published in:
- 2021
- By:
- Publication type:
- journal article
Evidence Supporting the Value of Surgical Procedures: Can We Do Better?
- Published in:
- 2021
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- Publication type:
- journal article
Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling.
- Published in:
- 2021
- By:
- Publication type:
- journal article
Patient Assistance Programs for Prescription Drugs: Charities or Kickbacks?
- Published in:
- Journal of Health & Life Sciences Law, 2021, v. 15, n. 2, p. 68
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- Publication type:
- Article
Comparing Onset of Biosimilar Versus Generic Competition in the United States.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 6, p. 1308, doi. 10.1002/cpt.1981
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- Publication type:
- Article
Efficacy and costs of spinal muscular atrophy drugs.
- Published in:
- Science Translational Medicine, 2020, v. 12, n. 569, p. 1, doi. 10.1126/scitranslmed.aay9648
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- Publication type:
- Article
Drug Shortages and the Defense Production Act.
- Published in:
- 2020
- By:
- Publication type:
- Editorial
Understanding when real world data can be used to replicate a clinical trial: A cross‐sectional study of medications approved in 2011.
- Published in:
- Pharmacoepidemiology & Drug Safety, 2020, v. 29, n. 10, p. 1273, doi. 10.1002/pds.5086
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- Publication type:
- Article
Origins and Ownership of Remdesivir: Implications for Pricing.
- Published in:
- Journal of Law, Medicine & Ethics, 2020, v. 48, n. 3, p. 613, doi. 10.1177/1073110520958890
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- Publication type:
- Article
Commentary: Expedited Regulatory Review of Low-Value Drugs.
- Published in:
- Healthcare Policy, 2020, v. 15, n. 4, p. 35
- By:
- Publication type:
- Article
FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
- Published in:
- 2020
- By:
- Publication type:
- journal article
Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?
- Published in:
- Open Forum Infectious Diseases, 2020, v. 7, n. 1, p. N.PAG, doi. 10.1093/ofid/ofaa001
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- Publication type:
- Article
Designing development programs for non-traditional antibacterial agents.
- Published in:
- Nature Communications, 2019, v. 10, n. 1, p. N.PAG, doi. 10.1038/s41467-019-11303-9
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- Publication type:
- Article
Approximating Future Generic Entry for New Drugs.
- Published in:
- Journal of Law, Medicine & Ethics, 2019, v. 47, n. 1, p. 177, doi. 10.1177/1073110519840499
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- Publication type:
- Article
The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents.
- Published in:
- Applied Health Economics & Health Policy, 2019, v. 17, n. 1, p. 47, doi. 10.1007/s40258-018-0420-8
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- Publication type:
- Article
The US Biosimilar Market: Stunted Growth and Possible Reforms.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 1, p. 92, doi. 10.1002/cpt.1285
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- Publication type:
- Article
An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?
- Published in:
- Nature Biotechnology, 2019, v. 37, n. 1, p. 21, doi. 10.1038/nbt.4324
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- Publication type:
- Article
The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
- Published in:
- 2017
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- Publication type:
- journal article
A New Approach to Treat Childhood Leukemia: Novartis' CAR-T Therapy.
- Published in:
- Journal of Law, Medicine & Ethics, 2017, v. 45, n. 4, p. 692, doi. 10.1177/1073110517750609
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- Publication type:
- Article
Will inter partes review speed US generic drug entry?
- Published in:
- Nature Biotechnology, 2017, v. 35, n. 12, p. 1139, doi. 10.1038/nbt.4036
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- Publication type:
- Article
PHARMACEUTICAL GATEKEEPERS.
- Published in:
- Indiana Law Review, 2014, v. 47, n. 2, p. 363
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- Publication type:
- Article
Crowdsourcing Clinical Trials.
- Published in:
- Minnesota Law Review, 2014, v. 98, n. 3, p. 805
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- Publication type:
- Article
Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.
- Published in:
- Journal of Law, Medicine & Ethics, 2013, v. 41, n. 3, p. 590, doi. 10.1111/jlme.12068
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- Publication type:
- Article
Pharmaceutical Efficacy: The Illusory Legal Standard.
- Published in:
- Washington & Lee Law Review, 2013, v. 70, n. 4, p. 2073
- By:
- Publication type:
- Article
Recent Developments in Health Law.
- Published in:
- Journal of Law, Medicine & Ethics, 2011, v. 39, n. 2, p. 291, doi. 10.1111/j.1748-720X.2011.00599.x
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- Publication type:
- Article
SECONDARY CONSIDERATIONS: A STRUCTURED FRAMEWORK FOR PATENT ANALYSIS.
- Published in:
- Albany Law Review, 2011, v. 74, n. 1, p. 47
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- Publication type:
- Article
THE NEGLECTED DIMENSION OF PATENT LAW'S PHOSITA STANDARD.
- Published in:
- Harvard Journal of Law & Technology, 2009, v. 23, n. 1, p. 227
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- Publication type:
- Article
The Search Engine Advertising Market: Lucrative Space or Trademark Liability?
- Published in:
- Texas Intellectual Property Law Journal, 2009, v. 17, n. 2, p. 223
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- Publication type:
- Article