Transparency practices at the FDA: A barrier to global health-Reference-Cited by-同舟云学术

Transparency practices at the FDA: A barrier to global health

Published:2022-08-05 Issue:6606 Volume:377 Page:572-574
ISSN:0036-8075
Container-title:Science
language:en
Short-container-title:Science

Author:

Lumpkin Murray M.¹,Hamburg Margaret A.²,Schultz William B.³,Sharfstein Joshua M.⁴

Affiliation:

1. Bill & Melinda Gates Foundation, Seattle, WA, USA.

2. Independent researcher, Washington, DC, USA.

3. Zuckerman Spaeder, Washington, DC, USA.

4. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21209, USA.

Abstract

Data sharing among regulators must be “business as usual”

Publisher

American Association for the Advancement of Science (AAAS)

Subject

Multidisciplinary

Reference10 articles.

1. WHO, “List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4)” (WHO, 2022); https://www.who.int/initiatives/who-listed-authority-reg-authorities/maturity-level.

2. US National Academies of Science Engineering and Medicine “Mutual recognition agreements in the regulation of medicines” (2019); https://www.nationalacademies.org/our-work/mutual-recognition-agreements-in-the-regulation-of-medicines.

3. WHO, “TRS 1033 - 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations” (WHO, 2021); https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations.

4. Public information; Communications with Foreign Government Officials. Fed. Regist. 58 (223) 61598 ff (19 November 1993).

5. FDA Confidentiality commitments; https://www.fda.gov/internationalprograms/international-arrangements/confidentiality-commitments.

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