Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 3, 2020
April 3, 2020
56f9622b-7869-4157-b784-d3446072e7da
Related Documents
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final
Guidance DocumentDecember 12, 2017Center for Drug Evaluation and Research
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance DocumentOctober 8, 2015Center for Drug Evaluation and Research
Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance DocumentNovember 24, 2014Center 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