LexisNexis Reed Tech
Knowledge Center
Explore our library of blogs, short videos, virtual event recordings and training topics
Recent Blogs
MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed
On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.
Update on EUDAMED Timeline
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.
Navigating the AusUDID Rollout: A New Era for Medical Device Identification
Explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.
Health Canada Releases XML PM Draft Guidance
Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files.
Revisions to FDA-Forms 365h and 1571
The US Food and Drug Administration (FDA) has recently made updates to forms 365h and 1571. Form 365h is “Application to Market a New or Abbreviated New Drug or Biologic for Human Use”. These applications are commonly referred to as NDA, ANDA or BLA. Form 1571 is “Investigational New Drug Application (IND)”. These are among the most important eCTD forms involved in your drug or biologic application process.
FDA Releases MoCRA Draft Guidance
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act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.