viernes, 14 de agosto de 2015

CDER SBIA Update: New Guidance Documents and Notices

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

 New Guidance Documents and Notices

1. Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen; Guidance for Industry
This guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over-the-counter or OTC, pediatric oral liquid acetaminophen drug products. This guidance provides recommendations regarding acetaminophen concentration, container labels, carton labeling, and packaging of such products, as well as for any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.

2. Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry
This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.

3. Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Correction
The FDA is correcting a notice that appeared in the Federal Register of July 28, 2015 (80 FR 44973). The document published with an incorrect docket number. This document corrects that error.

4. Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date
FDA is extending the closing date in the notice published June 3, 2015 (80 FR 31602). Stakeholders should submit notification of intent to participate by April 30, 2016. Federal Register Notice  

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

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