Can I read Conditional Approval Act for Drugs on EtoBox?

Conditional Approval Act for Drugs by SMB116 is a document available to read on EtoBox.

What is Conditional Approval Act for Drugs about?

The document proposes legislation to establish a conditional approval pathway for certain drugs. The pathway would provide provisional and time-limited approval for drugs intended to treat serious diseases if additional data is likely to be provided and expected benefits outweigh risks. The approval would be conditional on completing studies within set timelines and agreeing to labeling and reporting requirements.

Author

SMB116

Language

EN