M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 30, 2024
November 1, 2024
3432d6e2-cab4-4cd5-8507-43579051debb
Related Documents
Requests for Reconsideration at the Division Level Under GDUFA
Guidance DocumentOctober 16, 2024Center for Drug Evaluation and Research
Providing Over-the-Counter Monograph Submissions in Electronic Format
Guidance DocumentJuly 25, 2024Center for Drug Evaluation and Research
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance for Industry
Guidance DocumentJune 14, 2024Center 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