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FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials

Oct 8th, 2012

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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.

[The story continues for subscribers beginning on page 2 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 Peter Blachly ([email protected]).  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

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