PorzioLS Vice President of Distribution and Licensing Services and Porzio, Bromberg & Newman principal Frank Fazio testified before the New Jersey Senate Health Committee in support of bill S2024, which he also drafted. S2024 was introduced in the Senate on April 18, 2016 and referred to the Senate Health, Human Services and Senior Citizens Committee.
The bill clarifies that product approval from the U.S. Food and Drug Administration (FDA) is not required in order for a drug manufacturer to file a registration statement. If a registrant's product has not been approved by the FDA prior to filing, the registrant must submit a statement confirming that an application has or will be filed with the FDA within 12 months. FDA approval will not be a condition of registration. S2024 further requires the Department of Health to review registration statements and reply to the registrant within 30 days of receipt.
The committee voted unanimously to release it for a second reading before the full senate. The bill is co-sponsored by Senator Fred H. Madden, Jr. of District 4 (Camden and Gloucester) and Senator Steven V. Oroho of District 24 (Morris, Sussex and Warren).
The full text for S2024 may be found here.