FDA Pushes DSCSA Serialization Enforcement Deadline to 2018
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
On June 30, 2017, FDA published draft guidance on product identifiers and verification in connection with the US Drug Supply Chain Security Act (DSCSA).
Noting the fact that some pharmaceutical manufacturers still have not installed the technologies required, and acknowledging the limited number of vendors capable of offering solutions, as well as lack of readiness among contract manufacturers, FDA is now giving pharma companies until Nov. 26, 2018 to meet requirements.
This year, a number of surveys had shown that a significant number of small-to-mid-sized pharma companies were still not ready for serialization requirements required by DSCSA and the Nov. 27, 2017 compliance deadline. This additional time should allow them more time to examine the scope of work required and evaluate the best solutions.
Source: FDA
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
