Results 71 to 80 of about 478,778 (207)

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

Frontiers in Public Health, 2020
Background: Risk Evaluation and Mitigation Strategies (REMS) are safety programs that U.S. Food and Drug Administration can require to ensure a drug's benefits outweigh its risks and can be considered public health interventions.
Gita A. Toyserkani, Linda Huynh, Linda Huynh, Elaine H. Morrato, Elaine H. Morrato   +4 more
doaj   +1 more source

Botulinum toxin type A for the management of glabellar rhytids [PDF]

, 2010
There is an increasing demand for minimally-invasive cosmetic procedures to arrest the aging process. Botulinum toxin type A injections are the most commonly used nonsurgical cosmetic procedures in the United States. There has been research spanning over
McCullough, Jerry L, Tremaine, Anne Marie   +1 more
core   +2 more sources

The ethics and politics of compulsory HPV vaccination [PDF]

, 2006
On September 12, 2006, 3 months after the Food and Drug Administration licensed a vaccine against human papillomavirus (HPV), Michigan lawmakers became the first in the United States to propose that vaccination be compulsory for girls entering sixth ...
Colgrove, James K.
core   +2 more sources

An Outbreak Investigation of Salmonella Typhimurium Illnesses in the United States Linked to Packaged Leafy Greens Produced at a Controlled Environment Agriculture Indoor Hydroponic Operation – 2021

Journal of Food Protection, 2023
In 2021, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state partners investigated a multistate outbreak of Salmonella Typhimurium illnesses linked to packaged leafy greens from a controlled ...
Monica McClure, Brooke Whitney, Ifueko Gardenhire, Alvin Crosby, Allison Wellman, Kane Patel, Zachary D. McCormic, Laura Gieraltowski, Lauren Gollarza, Mabel S.F. Low, Jennifer Adams, Arthur Pightling, Rebecca L. Bell, Kurt Nolte, Mary Tijerina, Joseph T. Frost, James A. Beix, Karen A. Boegler, Julie Dow, Shana Altman, Matthew E. Wise, Michael C. Bazaco, Stelios Viazis   +22 more
doaj  

The Conflict Between the FDA’s Pre-Launch Activities Importation Request Program and the Hatch-Waxman Act [PDF]

, 2014
In 2008, the Food and Drug Administration (FDA) implemented the Pre- Launch Activities Importation Request (PLAIR) program. The FDA exercises its enforcement discretion under the guise of the PLAIR program to permit drug manufacturers to import ...
Avery, Matthew, Cheng, Alex
core   +1 more source

Forum: Enabling HIV self-testing in South Africa [PDF]

, 2012
In a South African context, we consider the implications of the United States Food and Drug Administration’s recent approval of the OraQuick HIV self-testing kit.
Gray, A, Richter, ML, Venter, WDF
core   +1 more source

Novel (Q)SAR models for prediction of reversible and time-dependent inhibition of cytochrome P450 enzymes

Frontiers in Pharmacology
The 2020 FDA drug-drug interaction (DDI) guidance includes a consideration for metabolites with structural alerts for potential mechanism-based inhibition (MBI) and describes how this information may be used to determine whether in vitro studies need to ...
Sadegh Faramarzi, Arianna Bassan, Kevin P. Cross, Xinning Yang, Glenn J. Myatt, Donna A. Volpe, Lidiya Stavitskaya   +6 more
doaj   +1 more source

Systems validation: application to statistical programs [PDF]

, 2005
BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which ...
D Moher, FDA, FDA, Rickey E Carter, T Stokes, T Stokes   +5 more
core   +3 more sources

Listeria monocytogenes Growth Kinetics in Milkshakes Made from Naturally and Artificially Contaminated Ice Cream

Frontiers in Microbiology, 2018
This study assessed the growth of Listeria monocytogenes in milkshakes made using the process-contaminated ice cream associated with a listeriosis outbreak in comparison to milkshakes made with artificially contaminated ice cream.
Joelle K. Salazar, Vriddi M. Bathija, Christina K. Carstens, Sartaj S. Narula, Arlette Shazer, Diana Stewart, Mary Lou Tortorello   +6 more
doaj   +1 more source

Imports From China and Food Safety Issues [PDF]

The U.S. Food and Drug Administration’s (FDA) increased attention to food imports from China is an indicator of safety concerns as imported food becomes more common in the United States. U.S.
Buzby, Jean C., Gale, H. Frederick, Jr.
core   +1 more source