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On June 30, 2017, FDA published draft guidance on product identifiers and verification in connection with the US Drug Supply Chain Security Act (DSCSA).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
Hesperos, Psilera Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
