Zdrowie i gospodarka · 03/11/1999

Agency Emergency Processing Request Under OMB Review; Guidance for Industry; Changes to an Approved NDA or ANDA

The Food and Drug Administration (FDA) is announcing that a collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The collection of information is contained in a guidance for industry entitled ``Changes to an Approved NDA or ANDA.'' The guidance is intended to assist applicants in determining how they should report changes to an approved new drug application (NDA) or abbreviated new drug application (ANDA) under section 116 of the Food and Drug Administration Modernization Act (the Modernization Act), which provides requirements for making and reporting manufacturing changes to an approved application and for distributing a drug product made with such changes.