jueves, 12 de junio de 2014

CDER SBIA Update: FDA guidance on content and format of ANDAs and associated webinar

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

FDA guidance on content and format of ANDAs and associated webinar
FDA published a notice in the Federal Register announcing the availability of a draft guidance for industry, entitled ANDA Submissions--Content and Format of Abbreviated New Drug Applications.
FDA is issuing this guidance to assist ANDA applicants in improving the quality of submissions, to increase the number of original ANDAs acknowledged for receipt upon initial submission, and to decrease the number of review cycles. The draft guidance provides comprehensive assistance for the early stages of the application process so that an original ANDA will contain all information necessary for FDA to complete its review.
A pre-recorded webinar explaining this guidance is available at https://collaboration.fda.gov/p6kfmalydi8/
Submit electronic comments on the draft guidance to http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4886.


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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