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64 research outputs found

Randomised, crossover clinical trial, in healthy volunteers, to compare the systemic availability of two topical intranasal budesonide formulations

Author: AL Boner
BJ Lipworth
C Möller
CE Baena-Cagnani
DB Allen
Emilio Sanz
HW Kelly
J Krahnke
Jaime Algorta
KK Midha
L Endrenyi
L Thorsson
Maria Angeles Pena
Silvia Francisco
SJ Szefler
The European Agency for the Evaluation of Medicinal Products (EMEA)
The European Agency for the Evaluation of Medicinal Products(EMEA)
The European Agency for the Evaluation of Medicinal Products(EMEA)
USA Food and Drug Administration
USA Food and Drug Administration
WR Lumry
Zurine Abajo
Publication venue: 'Springer Science and Business Media LLC'
Publication date
Field of study

Inter-ethnic differences in drug response: Implications for drug development and complying with drug regulation

THE PHOSPHODIESTERASE INHIBITORS AND NON-ARTERITIC ANTERIOR ISCHAEMIC OPTIC NEUROPATHY: INCREASED VIGILANCE IS NECESSARY

Author: Arnold AC
Boshier A
Egan RA
USA Food and Drug Administration.
Yee RD
Publication venue: 'Wiley'
Publication date
Field of study

Neurotoxicity of Ortho-Phthalates: Recommendations for Critical Policy Reforms to Protect Brain Development in Children

Author: Ahold Delhaize USA
Committee on the Design and Evaluation of Safer Chemical Substitutions
Committee on the Health Risks of Phthalates
Consumer Products Safety Commission
Environmental Protection Agency
Ma N
Ma N
US Food and Drug Administration
US Food and Drug Administration
US Food and Drug Administration
US Food and Drug Administration
Publication venue: 'American Public Health Association'
Publication date
Field of study

Modeling the Level of Fortification and Post-Fortification Assessments: U.S. Experience

Statistical considerations on implementing the MCP-Mod method for binary endpoints in clinical trials

Author: Bretz
European Medicines Agency (EMA)
Kaitin
Pinheiro
Pinheiro
Sacks
USA Food and Drug Administration (FDA)
Wang
Zhou
Publication venue: 'Elsevier BV'
Publication date
Field of study

The seafood list: FDA's guide to acceptable market names for seafood sold in interstate commerce, 1993

Author: Food and Drug Administration Washington, DC (USA). Office of Seafood
National Marine Fisheries Service Washington, DC (USA)
Snyder M.
Spring R.
Publication venue: Washington, DC (USA)
Publication date
Field of study

What is in commercial cat and dog food? The case for mercury and ingredient testing

Author: Ackerman
Adb-Elhakim
Afgan
American Veterinary Medical Association
Arnold
Arulandhu
Atkins
Ayaz
Bertolini
Blakley
Boyer
Cawthraw
Center for Veterinary Medicine Food and Drug Administration
Chang
Cima
Clean Label Project
Dalmasso
Deagle
Dobrovolny
EC European Commission
Farina
Farina
Farrar
Ferreira
Flores-Munguia
Galimberti
Gaschen
Goldstein
H.R. 5554
Hajibabaei
Hebert
Hellberg
Hellberg
Ivanova
Jennifer Reitman et al. v. Champion PetFoods USA Inc. et al
Leppert et al. v. Champion Petfoods USA Inc. et al
National Research Council
United States Department of Health and Human Services Food and Drug Administration
United States Department of Health and Human Services Food and Drug Administration
United States Food and Drug Administration
United States Food and Drug Administration
United States Food and Drug Administration
United States Food and Drug Administration Amendments Act of 2007
Publication venue: 'Elsevier BV'
Publication date
Field of study

A study of the migration of externally applied sucrose esters of fatty acids through the skins of banana, apple and pear fruits

Author: Banks
Daniel
Food and Drug Administration(USA)
Gupta
Lemieux
Lowings
Official Journal of the European Communities
Schuster
Spendley
Welch
Wieneke
Publication venue: 'Wiley'
Publication date
Field of study

Abuse-deterrent Opioid Formulations

Author: Institute for Clinical and Economic Review: Abuse-deterrent formulations of opioids: Effectiveness and value
Multistate Insider: States have stalled on potential opioid abuse solution: Deterrent formulation drugs
Office of National Drug Control Policy USA: National Drug Control Strategy
Office of National Drug Control Policy USA: National Heroin Task Force final report and recommendations
Pfizer Inc.: Embeda® (morphine sulfate and naltrexone HCl)
Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality: Results 2015 National Survey on Drug Use and Health: Detailed tables
U.S. Food and Drug Administration: Abuse-deterrent opioids—evaluation and labeling. Guidance for industry
U.S. Food and Drug Administration: Briefing document: Joint meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee
U.S. Food and Drug Administration: Center for Drug Evaluation and Research: Data and methods for evaluating the impact of opioid formulations with properties designed to deter abuse in the postmarket setting
U.S. Food and Drug Administration: Determination that the OxyContin (oxycodone hydrochloride) products covered by New Drug Application 20–553 were withdrawn from sale for reasons of safety or effectiveness
U.S. Food and Drug Administration: FDA actions on OxyContin products
U.S. Food and Drug Administration: FDA approves Targiniq ER with abuse-deterrent properties
U.S. Food and Drug Administration: FDA requests removal of Opana ER for risks related to abuse
U.S. Food and Drug Administration: Opioids action plan
U.S. Food and Drug Administration: Postmarketing safety issues related to reformulated Opana ER®
U.S. Food and Drug Administration: Sponsor briefing document: Arymo™ ER (morphine sulfate) extended-release tablets
U.S. Food and Drug Administration: Summary review for regulatory action: Hysingla® ER
Publication venue: 'Ovid Technologies (Wolters Kluwer Health)'
Publication date
Field of study

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