Change of address for BLA submissions
Executive Summary
As of Oct. 4, all therapeutic biologic submissions excluding 21 CFR 600.80 postmarketing adverse experience reports; advertising and promotional labeling; and 21 CFR 600.14 biological product deviation reports should be sent to CDER Therapeutic Biological Products Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 12229 Wilkins Ave., Rockville, MD 20852. FDA hopes to continue its normal pace of review, but "I do anticipate that it might slow things down a little bit," CDER Office of Compliance Therapeutics Facilities Review Branch Facility Reviewer Carolyn Renshaw said during the PDA/FDA Regulatory Conference in Washington, D.C. Sept. 22. "There is going to be a transition period. I do believe it will be difficult mailing and getting everything on time, which was difficult to begin with"...
You may also be interested in...
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.