The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
GDUFA Federal Register Notices FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation. These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation. The materials available include: - Federal Register Notice of Public Meeting on Generic Drug User Fee Amendments - Federal Register Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations - Federal Register Notice on Agency Information Collection Activities Please find this information at: GDUFA Federal Register Notices
- Guidance for Industry, Generic Drug User Fee Amendments: Questions and Answers
- Guidance for Industry, Self-Identification of Generic Drug Facilities, Sites and Organizations
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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