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CRISPR-phage antibacterials to address the antibiotic resistance crisis: scientific, economic, and regulatory considerations.

• Authors : Pacia, Danielle M; Brown, Beatrice L; Minssen, Timo

Subjects: DRUG resistance in bacteria; ANTIBACTERIAL agents; NEURONAL ceroid-lipofuscinosis

• Source: Journal of Law & the Biosciences; Jan-Jun2024, Vol. 11 Issue 1, p1-13, 13p

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Prioritizing Early Disease Intervention.

• Authors : Caicedo, H. Hugo; Darrow, Jonathan J.; Caicedo, Julio C.

• Source: Therapeutic Innovation & Regulatory Science; Nov2023, Vol. 57 Issue 6, p1148-1152, 5p

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Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process.

• Authors : Patel, Neeraj G.; Kesselheim, Aaron S.; Darrow, Jonathan J.

Subjects: DRUG approval; COMMITTEES; GOVERNMENT regulationUNITED States. Food & Drug Administration

• Source: Journal of Health Politics, Policy & Law; Oct2023, Vol. 48 Issue 5, p799-820, 22p, 1 Chart

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Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.

• Authors : Rand, Leah Z.; Carpenter, Daniel P.; Kesselheim, Aaron S.

Subjects: DRUG approval; COVID-19 vaccines; PRACTICAL politicsUNITED States. Food & Drug Administration

• Source: Hastings Center Report; Sep2023 Supplement 1, Vol. 53, pS60-S68, 9p, 1 Chart

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Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease.

• Authors : Dhruva, Sanket S.; Kesselheim, Aaron S.; Woloshin, Steven

Subjects: PHYSICIANS' attitudes; ADUCANUMAB; ALZHEIMER'S diseaseUNITED States. Food & Drug Administration

• Source: Clinical Pharmacology & Therapeutics; Sep2023, Vol. 114 Issue 3, p614-617, 4p

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Two views of cancer medicines: Imagery versus evidence.

• Authors : Darrow, Jonathan J.

Subjects: DRUG efficacy; HEALTH policy; ANTINEOPLASTIC agents

• Source: Health Marketing Quarterly; Apr-Jun2023, Vol. 40 Issue 2, p141-152, 12p, 5 Color Photographs

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Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review.

• Authors : Brown, Beatrice L.; Mitra-Majumdar, Mayookha; Joyce, Krysten

Subjects: DRUG approval; ONLINE information services; STRETCH (Physiology)UNITED States. Food & Drug Administration

• Source: Journal of Health Politics, Policy & Law; Dec2022, Vol. 47 Issue 6, p649-672, 24p, 2 Diagrams

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Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

• Authors : Dhruva, Sanket S.; Darrow, Jonathan J.; Kesselheim, Aaron S.

Subjects: RESEARCH funding; PATIENT care; INSTITUTIONAL review boardsUNITED StatesUNITED States. Food & Drug Administration

• Source: JGIM: Journal of General Internal Medicine; Dec2022, Vol. 37 Issue 16, p4176-4182, 7p, 2 Charts

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Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman Reply.

• Authors : Rand, Leah Z.; Carpenter, Daniel P.; Kesselheim, Aaron S.

Subjects: PRIVACY; PUBLIC opinion; BIOETHICSUNITED States. Food & Drug Administration

• Source: Hastings Center Report; Mar2024, Vol. 54 Issue 2, p44-45, 2p

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Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.

• Authors : Brown, Beatrice L.; Mitra-Majumdar, Mayookha; Darrow, Jonathan J.

• Source: JAMA Internal Medicine; Nov2022, Vol. 182 Issue 11, p1223-1226, 4p

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