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FDA Releases MoCRA Draft Guidance
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
Embracing EUDAMED UDI Compliance Timing: Why Starting the Process Now is Crucial for Medical Device Manufacturers
EUDAMED UDI Compliance is a critical aspect of the European Medical Device Regulation (MDR) that requires...
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...