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Now Google is lending a hand by pinpointing 3,500 of these drop-off sites on Google Maps and via Search in partnership with the DEA, HHS, CVS, Walgreens and state governments.
MAPS works closely with government regulatory authorities worldwide such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure that all of its sponsored research protocols conform to ethical and procedural guidelines for clinical drug research. Included in MAPS' research efforts are MDMA ...
Drug checking or pill testing is a way to reduce the harm from drug consumption by allowing users to find out the content and purity of substances that they intend to consume. This enables users to make safer choices: to avoid more dangerous substances, to use smaller quantities, and to avoid dangerous combinations.
WEDINOS (an acronym for Welsh Emerging Drugs and Identification of Novel Substances) is a public health laboratory in Cardiff, Wales devoted to drug checking and epidemiological surveillance of recreational drugs and prescription drugs obtained from unsanctioned sources. It is the only fixed-site facility in the United Kingdom devoted to this task.
The Food and Drug Administration Modernization Act of 1997 (Public Act 105-115) [4] amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information resource, which came to be called ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational ...
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use ...
A fast track application is automatically considered for both of these designations. Rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review ...