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  5. FDA posts one final and one draft guidance for industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits
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FDA posts one final and one draft guidance for industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits

FDA posts one final and one draft guidance for industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits

Today FDA published notices in the Federal Register announcing the availability of one final and one draft guidance for industry:

 
 
 
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.
  
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President of the United States of America.  GDUFA was designed to speed the delivery of safe, effective, and high-quality generic drugs to the public.  This program will bring greater predictability and timeliness to the review of generic drug applications.  GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry.