Pipeline · Bill → Law
Step 1
Introduced
Mar 30, 2023
Step 2
Referred
Mar 30, 2023
HELP
Step 3
Committee
May 11, 2023
Reported out
Step 4
Senate
Jun 22, 2023
Step 5
House floor
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS Summary
This bill modifies provisions related to market exclusivity for a generic drug. Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug. The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of...
Timeline · 5 actions
Jun 22, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
Jun 22, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 108.
May 11, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Mar 30, 2023
Introduced in Senate
Mar 30, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.