Meeting on NDC changes
FDA will hold a public meeting Dec. 11 to discuss proposed changes to the National Drug Code system contained in an August proposed rule governing drug establishment registration and listing. The proposed revisions would reorganize and modify regulations on who must list human drugs and biologics and require that the appropriate NDC number appear on the labels of all drugs subject to the listing requirements. The meeting will be held from 9 a.m. to 4 p.m. at 5630 Fishers Lane, Rockville, Md. FDA has also extended the deadline for submitting comments on the rule to Jan. 26...
You may also be interested in...
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.
US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.