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FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
In December 2014, the FDA CDER and CBER divisions released guidance for industry enforcing the usage of SEND as part of Investigational New Drug (IND) and Biologic License Application (BLA) submission to the US Food and Drug Administration. All studies started after December 15, 2016 supporting IND and BLA submissions will need to be compliant ...
Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. [1] RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). [2]
NextGen Healthcare Electronic Dental Record (EDR) Receives 2014 ONC HIT Certification Solution compliant with the ONC 2014 Edition criteria and certified as a Complete EHR HORSHAM, Pa.--(BUSINESS ...
NextGen Healthcare, Inc. is an American software and services company headquartered in Atlanta, Georgia. The company develops and sells electronic health record (EHR) software and practice management systems to the healthcare industry , as part of a range of software, services and analytics solutions for medical and dental practices.
Japanese technology giant SoftBank Group and OpenAI stepped up their AI partnership Monday, setting up a 50-50 held company called SB OpenAI Japan. Cristal will first roll out in Son’s own ...
Janet Woodcock (born August 29, 1948) is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). [2]