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Sustainability (Switzerland), ISSN 2071-1050, 05/2018, Volume 10, Issue 6
Food export rejection can be a harmful barrier to sustainable international food trade. To understand China's export food rejected by FDA (Food and Drug... 
Export rejection | Sustainable food trade | Food safety | U.S. FDA | China | food safety | sustainable food trade | SAFETY INCIDENTS | GREEN & SUSTAINABLE SCIENCE & TECHNOLOGY | ENVIRONMENTAL SCIENCES | STANDARDS | ENVIRONMENTAL STUDIES | US FDA | export rejection
Journal Article
European Journal of Pharmaceutical Sciences, ISSN 0928-0987, 01/2018, Volume 111, pp. 399 - 408
This review describes the EMA requirements on biowaivers for additional strengths of immediate release and modified release oral solid dosage forms focused on... 
Biowaiver | EMA | Strength | US-FDA | MULTIVARIATE STATISTICAL DISTANCE | PHARMACOLOGY & PHARMACY | RELEASE | Animals | European Union | Legislation, Drug | United States | Humans | United States Food and Drug Administration - legislation & jurisprudence | Drugs, Generic | Therapeutic Equivalency | Case studies | Generic drugs
Journal Article
Therapeutic Innovation & Regulatory Science, ISSN 2168-4790, 11/2016, Volume 50, Issue 6, pp. 734 - 742
Background: This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those... 
labeling comparison | CIRS | EMA | NDA comparison | US FDA | Swissmedic | MEDICAL INFORMATICS | PRODUCTS | PHARMACOLOGY & PHARMACY | Studies | Performance evaluation | Generic drugs | Regulatory agencies | Descriptive labeling | Decision making | Pharmaceutical industry | Drug dosages | Marketing
Journal Article
Journal Article
Chest, ISSN 0012-3692, 2016, Volume 151, Issue 1, pp. 23 - 33
Journal Article
SEMINARS IN ONCOLOGY, ISSN 0093-7754, 02/2017, Volume 44, Issue 1, pp. 8 - 12
The phrase "unmet medical need" has important regulatory implications, but there is no empirical analysis of its real world usage. We sought to determine the... 
Regulation | ONCOLOGY | US FDA | Unmet medical need | Cancer drug approval | DRUGS | United States | Humans | Neoplasms - mortality | Antineoplastic Agents - therapeutic use | Drug Approval | Neoplasms - epidemiology | United States Food and Drug Administration | Needs Assessment | Neoplasms - drug therapy
Journal Article
Journal Article
Journal Article
The Journal of Infectious Diseases, ISSN 0022-1899, 12/2017, Volume 216, Issue suppl_10, pp. S964 - S970
Abstract The Zika outbreak that began in 2015 has spread from Brazil to countries across the Western Hemisphere including the United States, presenting global... 
clinical development | licensure pathways | vaccine | US FDA | Zika | INFECTIOUS DISEASES | VIRUS | MICROBIOLOGY | IMMUNOLOGY | Zika Virus - immunology | Zika Virus Infection - virology | Public Health | United States | Humans | Licensure | Viral Vaccines | Zika Virus Infection - prevention & control | United States Food and Drug Administration | Supplement
Journal Article
Xenobiotica, ISSN 0049-8254, 01/2010, Volume 40, Issue 1, pp. 24 - 37
Transporters are carrier proteins that may influence pharmacokinetic, pharmacodynamic, and toxicological characteristics of drugs. The... 
transporters | US Food and Drug Administration (US FDA) | OATP1B1 | validation | in vitro | regulatory | Validation | Regulatory | Transporters | OATP1B | In vitro
Journal Article