Results 11 to 20 of about 999,693 (251)
The drug approval tactician [PDF]
Nature Reviews Drug Discovery, 2003 Regulatory affairs in the pharmaceutical industry is both a familiar and unfamiliar world. The industry is well known as being one of the most highly regulated, revolving around the approval of new compounds that emerge from the drug development pipeline by national or multinational regulatory bodies.
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Drugs, Devices, and the FDA: Part 1
JACC: Basic to Translational Science, 2016 Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
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Adapting drug approval pathways for bacteriophage-based therapeutics
Frontiers in Microbiology, 2016 The global rise of multi-drug resistant bacteria has resulted in the notion that an antibiotic apocalypse is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long
Callum Cooper +3 more
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Revista Panamericana de Salud Pública, 2022 Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin ...
Ivar T. van der Zee +3 more
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Pharmacy, 2022 The “breakthrough therapy” designation (BTD) is a recent mechanism implemented by the United States Food and Drug Administration (FDA) to expedite access to drugs that address unmet needs.
Megan C. Herink +4 more
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Product Complexity and Strategic Alliance on Drug Approval
American Business Review, 2021 Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA)
Taoyong Su +3 more
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Journal of Pharmaceutical Policy and Practice, 2017 Background The WHO Model List of Essential Medicines for Children (EMLc) covers medicines for globally high-burden diseases. Regulatory approval in high-income countries ensures evidence and dosage form but usually focuses on diseases common in those ...
Rumiko Shimazawa, Masayuki Ikeda
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Overcoming the Declining Trends in Innovation and Investment in Cardiovascular Therapeutics
JACC: Basic to Translational Science, 2017 Eroom’s law (Moore’s law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades.
Gail A. Van Norman, MD
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Trends in FDA drug approvals over last 2 decades: An observational study
Journal of Family Medicine and Primary Care, 2020 Introduction: The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important ...
Angelika Batta +2 more
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Pragmatic clinical trials in the context of regulation of medicines
Upsala Journal of Medical Sciences, 2019 The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data.
Rolf Gedeborg +3 more
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