The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
On July 25, 2013, FDA will present two individual webinars on two new guidances. These webinars will provide an opportunity to learn about the guidances from individuals involved in their preparation. They are also intended to encourage the submission of questions or comments while the guidance is still in draft form. Questions may be submitted online during the webinar and will be addressed as time permits. All questions should also be submitted to docket so that they can be formally processed by FDA. For further information, please click on the individual guidance: Draft Guidance For Industry On Rheumatoid Arthritis - Developing Drug Products For Treatment
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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