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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance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purpose of the draft guidance is to assist sponsors in the development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.
- Email: CDERSmallBusiness@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/
smallbusinessdrugs - Widget: http://www.fda.gov/Drugs/
ucm153379.htm
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