martes, 7 de octubre de 2014

CDER SBIA Update: New Notices and Guidance Documents

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

1. FDA Announces Fiscal Year 2015 Regulatory Science Priorities under the Generic Drug User Fee Amendments (GDUFA) of 2012
The FDA has published the fiscal year 2015 regulatory science priorities for generic drugs.  The FY 2015 research priorities list was prepared based on comments received at the May 16, 2014, public meeting, comments submitted to the public docket, scientific issues raised in citizen petitions, meeting request and controlled correspondence topics, tracked safety issues and discussions within FDA's Center for Drug Evaluation and Research.
To comply with this GDUFA requirement, the FDA Office of Generic Drugs developed the following fiscal year (FY) 2015 regulatory science priorities for generic drugs:
- Post-market evaluation of generic drugs
- Equivalence of complex products
- Equivalence of locally-acting products
- Therapeutic equivalence evaluation and standards
- Computational and analytical tools
For more information on GDUFA regulatory science programs and initiatives, please visit our GDUFA Regulatory Science web page.

2. Manual of Policy and Procedures (MAPP) on CDER Co-Sponsorship Agreements for Events
The purpose of this MAPP (MAPP 4100.1) is to ensure consistency and continuity across CDER as the Center engages in not-for-profit events (e.g., conferences, meetings, symposia, webinars, and workshops) co-sponsored with outside non-Federal organizations that provide relevant expertise and share a mutual interest and benefit in the subject matter. Pursuant to this MAPP, a network of CDER Co-Sponsorship Coordinators will be established to manage CDER co-sponsorships with outside organizations. 

3. Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2015
FDA is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the rare pediatric disease priority review fee rate for FY 2015 and outlines the payment procedures for such fees.

4. Guidance for Industry: Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval

This guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant (preoperative) setting using pathological complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations. Despite advances in systemic therapy of early-stage breast cancer over the past few decades, there remains a significant unmet medical need for certain high-risk or poor prognosis populations of early-stage breast cancer patients. This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012.

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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