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GENERAL INSTRUCTIONS. The New Drug Application (NDA) holder must submit patent information to its NDA using the appropriate form (see 21 CFR 314.53(d)). Use this Form FDA 3542 only if the NDA...
Subject. Patent Information Submitted Upon and After Approval of an NDA or Supplement for Each Patent That Claims a Drug Substance \(Active Ingredient\), Drug Product \(Formulation or...
DoD forms satisfy a valid need; essential to accomplish a mission and necessary for the efficient and economical operation of the DoD. This web site provides the “Official” edition of Department of Defense (DD) and Secretary of Defense (SD) forms.
Form FDA 3542 – Used to submit patent information on a patent that claims the following: • An . approved . drug • An . approved . method of using the drug
This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) within thirty (30) days after approval of an NDA or supplement or within thirty (30) days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii) at the
FORM FDA 3542a Author: PSC Publishing Services Subject: Patent Information Submitted with the Filing of an NDA, Amendment, or Supplement for Each Patent That Claims a Drug Substance \(Active Ingredient\), Drug Product \(Formulation and Composition\) and/or Method of Use Created Date: 12/23/2019 2:09:56 PM
DOD Issuances website combines all DOD Instructions, publications and directives. This site does not include forms.
