Conditional Approval Act This bill authorizes the Food and Drug Administration to conditionally approve certain new drugs intended for diseases that are seriously debilitating, life threatening, or chronic, and for which meaningful treatments do not exist. The bill also limits liability related to these conditionally approved drugs.
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Conditional Approval Act
USA116th CongressS-3133| Senate
| Updated: 12/19/2019
Conditional Approval Act This bill authorizes the Food and Drug Administration to conditionally approve certain new drugs intended for diseases that are seriously debilitating, life threatening, or chronic, and for which meaningful treatments do not exist. The bill also limits liability related to these conditionally approved drugs.
Civil actions and liabilityDrug safety, medical device, and laboratory regulationHealth care coverage and accessHealth information and medical recordsLicensing and registrationsMarketing and advertisingMedical research