ComplianceOnline

ANDA Submissions: FDA Revised Refuse-to-Receive Guidance

  • By: Staff Editor
  • Date: April 11, 2017
  • Source: http://www.fda.gov
Abstract:

ANDA Submissions: FDA Revised Refuse-to-Receive Guidance

The US FDA has recently revised its guidance on standards for refuse-to receive (RTR) an abbreviated new drug application (ANDA). The updated guidance not only offers a broader definition for major deficiencies and but also downgraded four major deficiencies to minor ones to make requirements less cumbersome for industry.

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