The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA posts one final and one draft guidance for industry: ANDA Submissions –
Refuse-to-Receive Standards and ANDA Submissions –
Refuse-to-Receive for Lack of Proper Justification of Impurity Limits
Yesterday, FDA published notices in the Federal Register announcing the availability of one final and one draft guidance for industry:
Guidance For Industry: ANDA Submissions - Refuse-to-Receive Standards (RTR Standards guidance) (Final Guidance): Assists applicants preparing to submit abbreviated new drug applications (ANDAs), and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance highlights serious deficiencies in the application ANDA or new strength PAS that may cause FDA to refuse-to-receive the submission. You can access the Federal Register notice and docket for this guidance here.
Draft Guidance for Industry: ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (RTR Impurities guidance): Assists applicants preparing to submit to FDA ANDAs and PASs to ANDAs, for which the applicant is seeking approval of a new strength of the drug product. Highlights deficiencies in information about impurities that may cause FDA to refuse-to-receive an ANDA or new strength PAS. You can access the Federal Register notice and docket for this guidance here.
These guidances provide applicants with information on deficiencies that may cause FDA to refuse to receive an ANDA or new strength PAS. FDA is issuing these guidances as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.
A pre-recorded webinar explaining these guidances is available at:
Submit electronic comments on the draft guidances to www.regulations.gov.
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.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
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