A new system for the registration of medical gases and FDA participation in standard setting for nanotechnology particle-containing products are among the provisions in the catch-all Title XI of the Food and Drug Administration Safety and Innovation Act (FDASIA) that will further the Act’s impact on CMC and GMP regulatory processes.
Other of the 11 titles in FDASIA with significant CMC/GMP implications include: ● Titles I-IV on user fees user fees ● Title VII on the supply chain, and ● Title X on drug shortages. (See IPQ “The News in Depth” October 8, 2012 and other related stories listed below.)
As is often the case in Congressional legislation, many of the provisions in Title XI represent a codification of significant initiatives already underway at the agency.
Under Subtitle B of Title 11 on medical gases – which have been marketed in the past without agency involvement – will now need to be registered with FDA, with the exception of seven commonly-used gases that will be considered “designated.”
The designated gases are: ● oxygen ● nitrogen ● nitrous oxide ● helium ● carbon monoxide ● carbon dioxide, and ● medical air.
[CLICK HERE for the complete story.and includes coverage of the Title XI sections on nanomaterials, electronic new drug applications, regulation of internet pharmacies, and the advancement of regulatory science. Nonsubscribers can purchase the story by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
See related stories:
FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft
GDUFA Expectations for Fee Payment and Facility Registration Out for Comment; Public Meeting Scheduled
GPhA Weighs In On API and QbD Issues Needing Clarification for Generics; OGD Outlines Starting Material Expectations
FDA’s Proposed Biosimilar User Fee Structure Explained to Congress by CDER’s Woodcock
FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees