viernes, 6 de febrero de 2015

CDER SBIA Update: GDUFA Comment Period; Leadership in a Global Supply Chain Conference; Gastroenterology Regulatory Endpoints Workshop

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

GDUFA Comment Period; Leadership in a Global Supply Chain Conference; Gastroenterology Regulatory Endpoints Workshop

1. FDA Reopens Comment Period for GDUFA Public Hearing on Policy Development

FDA has posted a Federal Register notice reopening the public docket to solicit comments on certain topics related to Generic Drug User Fee Amendments of 2012 (GDUFA) implementation and the GDUFA Commitment Letter that accompanies the legislation.

FDA will reopen the comment period to the public docket associated with the GDUFA Public Hearing on Policy Development for an additional 30 days. The public hearing was announced in the Aug. 19, 2014 Federal Register and held on Sept. 17, 2014 (FDA-2014-N-1168).

The agency has requested public input on the five draft guidance documents that were issued to facilitate implementation of GDUFA and on future policy priorities including recommendations for additional guidance topics to facilitate GDUFA implementation. FDA also requested feedback on issues that may arise in consideration of 180-day exclusivity provided for by paragraph IV patent certifications (section 505(j)(5)(b)(iv) of the FD&C Act). Finally, FDA requested feedback on the specific criteria FDA that should apply to identify an abbreviated new drug application (ANDA) as a first generic eligible for expedited ANDA review. FDA is no longer seeking comment on the first generic review prioritization category at this time. FDA will take the information presented at the public hearing and in comments to the docket into account when developing the fiscal year 2015 GDUFA priorities.

The Agency is reopening the docket in response to requests that FDA provide an additional opportunity to submit comments on these topics.

For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website.

2. Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain

The FDA Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.” The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives.

The public conference will be held on March 25-27, 2015 on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 513-745-3020.

Please refer to the Federal Register Notice for additional information.

3. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop

FDA/CDER, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).” The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease.

The public workshop will be held on March 30 and 31, 2015, from 8:30 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.

Please refer to the Federal Register Notice for additional information.

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.