Kaival Brands (OTCQB: KAVL) Issues Statement Prioritizing Compliance with the Tobacco Control Act and the PACT Act marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.
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On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and Cosmetics Act (FDCA). The Ensuring Innovation Act exchanges the term “active ingredient” with the term “active moiety” in sections of the FDCA governing NCE and ODE.
The five-year NCE exclusivity provision contained in the FDCA states in part:
If an application submitted under subsection (b) for a drug, no
active ingredient (
including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after September 24, 1984, no application may be submitted under this subsection . . . before the expiration of five years from the date of the approval of the application under subsection (b) . . . .
Local health officials react to Johnson & Johnson vaccine pause thenewsenterprise.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thenewsenterprise.com Daily Mail and Mail on Sunday newspapers.