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(2) A statement whether the submission is an original submission, a 505(b)(2) application, a resubmission, or a supplement to an application under 314.70. (3) A statement whether the applicant proposes to market the drug product as a prescription or an overthecounter product.
In 2006, with renewed FDA interest, the industry met to revive SEND and work on a version that, with FDA backing, would cover regulatory submission as well as operational data transfer needs. By 2007, an FDA pilot was announced, during which time the SEND team worked on the SENDIG (implementation guide).
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4] However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [ 5 ] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. [1] RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). [2]