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  • NJ S2024
  • Clarifies that product approval from U.S. Food and Drug Administration is not required for drug manufacturer to file registration statement, and specifies timeframe by which DOH must review registration statements.
Introduced
(4/18/2016)
In Committee
(10/6/2016)
Crossed Over
(6/30/2016)
Passed
(10/20/2016)
Signed
(12/5/2016)
Dead/Failed/Vetoed
2016-2017 Regular Session
This bill would clarify that approval by the U.S. Food and Drug Administration (FDA) is not required when a drug manufacturer is filing a registration statement. If, at the time of filing, a registrant's drug products have not yet been approved by the FDA, the registrant will be required only to submit a statement confirming that an application for approval has been submitted to the FDA, or that the registrant intends to file such an application within 12 months. The bill specifies that FDA approval will not be a condition of registration. The bill further specifies that the Department of Health will be required to promptly review any completed registration statement submitted thereto, and, within 30 days after receipt of a registration statement, will be required to either issue the registration, or advise the registrant, in writing, of the specific deficiencies in the registration statement. The department will have an additional 30 days to review any subsequently submitted materials.
2nd Reading in the Assembly, 2nd Reading in the Senate, Bills and Joint Resolutions Signed by the Governor, Health and Senior Services, Health, Human Services and Senior Citizens, Passed both Houses
Approved P.L.2016, c.73.  (on 12/5/2016)
 
 

Date Chamber Action Description
12/5/2016 A Approved P.L.2016, c.73.
10/20/2016 A Passed Assembly (Passed Both Houses) (73-0-0)
10/20/2016 A Substituted for A3793
10/6/2016 A Reported out of Assembly Committee, 2nd Reading
10/6/2016 Assembly Health and Senior Services Hearing (10:00 10/6/2016 Committee Room 11, 4th Floor)
6/30/2016 A Received in the Assembly, Referred to Assembly Health and Senior Services Committee
6/30/2016 S Passed by the Senate (40-0)
5/16/2016 S Reported from Senate Committee, 2nd Reading
5/16/2016 Senate Health, Human Services and Senior Citizens Hearing (13:00 5/16/2016 Committee Room 1, 1st Floor)
4/18/2016 S Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee
Date Motion Yea Nay Other
Detail 10/20/2016 Assembly Floor: Third Reading - Final Passage 73 0 7
Detail 10/20/2016 Assembly Floor: Substitute For A3793 (Voice Vote) 0 0 0
Detail 10/6/2016 Assembly Health and Senior Services Committee: Reported Favorably 11 0 2
Detail 6/30/2016 Senate Floor: Third Reading - Final Passage 40 0 0
Detail 5/16/2016 Senate Health, Human Services and Senior Citizens Committee: Reported Favorably 9 0 0