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Page 4 - உணவு மற்றும் மருந்துகள் சட்டம் News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Kansas Ag-Gag Update - Food, Drugs, Healthcare, Life Sciences

Virginia Set To Become The 16th State To Legalize The Recreational Use Of Marijuana - Cannabis & Hemp

Missouri Meatless Meat Statute Update - Food, Drugs, Healthcare, Life Sciences

OEHHA Proposes Changes To Prop 65 Short Form Warnings - Environment

NCE Status Now Limited Active Moieties - Intellectual Property

To print this article, all you need is to be registered or login on Mondaq.com. On April 23 President Biden signed into law changes narrowing the scope of eligibility for the non-patent “new chemical entity” (NCE) 5-year exclusivity provisions of 21 U.S.C. §301 et seq. The 5-year exclusivity comprises a 4-year data exclusivity provision during which time a generic applicant cannot rely on the drug application to establish either safety or efficacy which is followed by a 1-year marketing exclusivity. The exclusivity provision found in 21 U.S.C. § 355 (c)(3)(E)(ii) prior to the amendment described the NCE as applying to a drug

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