Drugs FAQs

Drug Review

What information is provided to sponsors during the human drug product application review process?

How is a sponsor of a product application that is subject to PDUFA target dates informed about whether the review of its product application is on track to meet the target date for FDA action on the application?

Drug Approval

How can I better understand Patents and Exclusivity?

I wish to market an OTC drug product – where do I start?

I own a small pharmaceutical business. Am I eligible for, and if so, how do I apply for a PDUFA waiver?

How do I go about getting a drug approved?

I am a small business owner, where can I find information specific for me?

Import and Export

What must I do to import a human drug product that has been approved by the FDA into the US?

What must I do to export a human drug product from the US?

Guidances

Where can I find industry guidances applicable to human drug products? How can I easily retrieve newly added guidances?

Drug Registration and Listing

If I am required to register my drug facility and list my drug product, how do I proceed?