miércoles, 10 de julio de 2013

CDER Small Business Update

FDA/CDER's Small Business Assistance

As the Generic Drug User Fee Amendments of 2012 (GDUFA) approaches the first anniversary of its enactment, the program has achieved a number of significant milestones.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria).

The U.S. Food and Drug Administration is announcing a day-long public meeting on July 12, 2013 to discuss how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business 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 SBA 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/cdersmallbusiness

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