Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 28, 2014
January 26, 2021
5692d0bf-a0d8-4160-becb-4c084297e485
Related Documents
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
Guidance DocumentOctober 21, 2024Center for Drug Evaluation and Research
Attachement - Qualification Process for Drug Development Tools: Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease
Guidance DocumentJanuary 10, 2014Center for Drug Evaluation and Research
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance
Guidance DocumentFebruary 25, 2013Center 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