Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 22, 2004
May 4, 2020
1aafb7d9-76d0-4fff-8835-a361bbb77c9b
Related Documents
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
Guidance DocumentJuly 1, 2003Center for Drug Evaluation and Research
Changes to an Approved NDA or ANDA: Guidance for Industry
Guidance DocumentApril 8, 2004Center for Drug Evaluation and Research
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics
Guidance DocumentMarch 14, 2006Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox