Results 21 to 30 of about 478,778 (207)

Investigation of microorganisms in cannabis after heating in a commercial vaporizer

Frontiers in Cellular and Infection Microbiology, 2023
IntroductionThere are concerns about microorganisms present on cannabis materials used in clinical settings by individuals whose health status is already compromised and are likely more susceptible to opportunistic infections from microbial populations ...
Danielle S. Sopovski, Jing Han, Marla Stevens-Riley, Qiang Wang, Bruce D. Erickson, Berk Oktem, Michelle Vanlandingham, Cassandra L. Taylor, Steven L. Foley   +8 more
doaj   +1 more source

Inhaled Insulin: Intrapulmonary or Intranasal? [PDF]

, 2012
Initial attempts delivered the insulin hormone intramuscularly, intravenously, and eventually subcutaneously. Other routes of administration of the drug were explored.
Danish Ahmed, Shivangi Jaiswal, Shruti Mishra, Sweta Kumari   +3 more
core   +2 more sources

Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]

, 2013
This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges.
Hamill, P.A., McIlkenny, P., Opong, K.K.
core   +1 more source

Adaptability of AI for safety evaluation in regulatory science: A case study of drug-induced liver injury

Frontiers in Artificial Intelligence, 2022
Artificial intelligence (AI) has played a crucial role in advancing biomedical sciences but has yet to have the impact it merits in regulatory science. As the field advances, in silico and in vitro approaches have been evaluated as alternatives to animal
Skylar Connor, Ting Li, Ruth Roberts, Ruth Roberts, Shraddha Thakkar, Zhichao Liu, Weida Tong   +6 more
doaj   +1 more source

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Frontiers in Medicine, 2023
The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency.
Kimberly Chiu, Rebecca Racz, Keith Burkhart, Jeffry Florian, Kevin Ford, M. Iveth Garcia, Robert M. Geiger, Kristina E. Howard, Paula L. Hyland, Omnia A. Ismaiel, Naomi L. Kruhlak, Zhihua Li, Murali K. Matta, Kristin W. Prentice, Kristin W. Prentice, Aanchal Shah, Aanchal Shah, Lidiya Stavitskaya, Donna A. Volpe, James L. Weaver, Wendy W. Wu, Rodney Rouse, David G. Strauss   +22 more
doaj   +1 more source

Will Consumers be in the Dark about Labels on Genetically Engineered and Modified Foods? [PDF]

, 2021
In the 1900s, the United States began to sell genetically engineered foods. One of the first genetically engineered foods sold in the United States and approved by the Food and Drug Administration (FDA) was the Flavr Savr tomato.
Nat, Hilary
core   +1 more source

Through the looking glass: understanding non-inferiority [PDF]

, 2011
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United ...
BL Wiens, DB Petitti, EMA Committee for Medicinal Products for Human Use (CHMP), EMA Committee for Proprietary Medicinal Products (CPMP), J Wittes, Janet T Wittes, Jennifer Schumi, KK Teo, M Rothmann, MD Rothmann, N Mantel, R DerSimonian, R Temple, S Snappin, S Snappin, S Yusuf, SS Ellenberg, TR Fleming, TR Fleming, United States Food and Drug Administration   +19 more
core   +3 more sources

Food and drug administration approval process for dermatology drugs in the United States

Journal of Dermatological Treatment, 2018
The purpose of this review is to elucidate the steps involved in the FDA's approval of new dermatology drugs.To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals).In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three ...
Emily Boozalis, Yevgeniy R. Semenov, Shawn G. Kwatra   +2 more
openaire   +3 more sources

Microbiomes Associated With Foods From Plant and Animal Sources

Frontiers in Microbiology, 2018
Food microbiome composition impacts food safety and quality. The resident microbiota of many food products is influenced throughout the farm to fork continuum by farming practices, environmental factors, and food manufacturing and processing procedures ...
Karen G. Jarvis, Ninalynn Daquigan, James R. White, Paul M. Morin, Laura M. Howard, Julia E. Manetas, Andrea Ottesen, Padmini Ramachandran, Christopher J. Grim   +8 more
doaj   +1 more source

Prevalence of Antimicrobial Resistance in Select Bacteria From Retail Seafood—United States, 2019

Frontiers in Microbiology, 2022
In 2019, the United States National Antimicrobial Resistance Monitoring System (NARMS) surveyed raw salmon, shrimp, and tilapia from retail grocery outlets in eight states to assess the prevalence of bacterial contamination and antimicrobial resistance ...
Heather Tate, Sherry Ayers, Epiphanie Nyirabahizi, Cong Li, Stacey Borenstein, Shenia Young, Crystal Rice-Trujillo, Sanchez Saint Fleurant, Sonya Bodeis-Jones, Xunde Li, Melissa Tobin-D’Angelo, Victoriya Volkova, Rachel Hardy, Lisa Mingle, Nkuchia M. M’ikanatha, Laura Ruesch, Chris A. Whitehouse, Gregory H. Tyson, Errol Strain, Patrick F. McDermott   +19 more
doaj   +1 more source