The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
In an effort to assist review divisions with processing IND applications received from academic investigators, a new web navigational tool informing investigators about IND procedures has been posted at: The tool is intended for a broad audience of academic investigators, small pharmaceutical businesses, and anyone searching for brief explanations about various aspects of IND application submissions and procedures. The new tool: • Promotes understanding of IND application submission processes • Provides regulatory information to enable IND application submissions • Provides an overview of “lifecycle” of an IND application • Separates types of IND applications for clinical investigation and clinical treatment • Provides concise explanations and links to available guidance documents, FDA forms, and online references. Investigator-Initiated Investigational New Drug (IND) Applications webpage
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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