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Understanding FDA Exemptions to Unique Device Identification (UDI) Requirements
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance...
Understanding FDA UDI Compliance Requirements for Medical Device Manufacturers
What are the potential consequences for medical device manufacturers not following through with product data...
FDA has Updated eCTD Guidance to Recommend Structure-Data Files
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
LexisNexis® Reed Tech expands portfolio to offer Electronic Common Technical Document Submission Publishing Services
LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the...
WHO Responds to Global Rx Dependency Crisis
Over the years, Global Health Authorities have begun to work towards regulatory harmonization. Of course, the World Health Organization (WHO), a special agency of the United Nations responsible for international public health and established in 1948, is often at the forefront of these efforts.
Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID
The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID).