USFDA Final Guidance for Industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits

FDA published notices in the Federal Register announcing the availability of one final and one draft guidance for industry: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. 

• Draft Guidance for Industry: ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (RTR Impurities guidance):  Assists applicants preparing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. 

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:

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - “Guidance for Industry: ANDA Submissions-Refuse-to-Receive Standards” and “Draft Guidance for Industry: ANDA Submissions-Refuse-to-Receive for Lack of Proper Justification of Impurity Limits.” – September 16, 2014