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Resources on pharmaceutics, pharmacokinetics, drug delivery systems, dosage forms, drug designs, pharmacology, and other related topics.
The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.
-Drug Design and Discovery
-Formulation Design and Pharmaceutical Technology
-Pharmacokinetics (PK), Pharmacodynamics (PD), Absorption, Distribution, Metabolism and Excretion (ADME)
-Translational Research and Individualized Medicines
-Biotechnology; this SIG currently has 1 focus group: Vaccine
-Analytical Sciences and Pharmaceutical Quality
-Regulatory Sciences; this SIG currently has 2 focus groups: Dissolution/In vitro drug release and BCS and Biowaivers