Competitive Generic Therapies Get Help With Development, But Not Goal Date
Executive Summary
Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.
Topics
- Subjects
- Generic Drugs
- Guidance Documents
- Regulation
- FDA
- Review Pathway
- Industries
- BioPharmaceutical
- Regions
- North America
Latest Headlines
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
PS124784
Ask The Analyst
Ask the Analyst is free for subscribers. Submit your question and one of our analysts will be in touch.
Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.
All fields are required.
PS124784
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.