jueves, 16 de octubre de 2014

CDER SBIA Update: New Guidance Documents

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

New Guidance Documents
1. Draft Guidance for Industry: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers
FDA has announced the availability of a draft guidance for industry titled: “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers."  FDA is issuing this guidance to assist stakeholders in understanding the effects of section 585 (Uniform National Policy) of the Food Drug and Cosmetic Act, which was added by the Drug Supply Chain Security Act (DSCSA).
The DSCSA establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain. It also requires FDA to establish federal standards for licensing of wholesale drug distributors and third party logistics providers. 
Section 585 sets forth a uniform national policy preempting states from establishing or continuing in effect certain standards and requirements related to prescription drug product tracing and licensing, wholesale distributors and third-party logistics providers. 
The docket to comment on the draft guidance is open until December 07, 2014.
To learn more about DSCSA implementation, please visit our web page.
Additional questions regarding the DSCSA can be e-mailed to DrugTrackandTrace@fda.hhs.gov. 

2. Draft Guidance for Industry: Critical Path Innovation Meetings
This draft guidance describes a Critical Path Innovation Meeting (CPIM), a means by which FDA's Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, government, and patient advocacy groups can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.

3. Draft Guidance for Industry: Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen
This draft guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of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 (OTC), acetaminophen-containing pediatric liquid drug products. This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding 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. 

4. Draft Guidance for Industry: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products

This draft guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE)exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products (fixed combinations). If the guidance is finalized, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of “new chemical entity,” regardless of whether that drug substance is approved alone or in certain fixed-combinations.

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.

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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