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  • NJ A3793
  • 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
(5/23/2016)
In Committee
(10/6/2016)
Crossed OverPassedSignedDead/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, Health and Senior Services, Substituted by another Bill
Substituted by S2024  (on 10/20/2016)
 
 

Date Chamber Action Description
10/20/2016 A Substituted by S2024
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)
5/23/2016 A Introduced, Referred to Assembly Health and Senior Services Committee
Date Motion Yea Nay Other
Detail 10/6/2016 Assembly Health and Senior Services Committee: Reported Favorably 11 0 2