Examples of Original NDA in a sentence
The declara- tions required by this section must be signed by the applicant or patent owner, or the applicant’s or patent owner’s attorney, agent (representa- tive), or other authorized official.(d) When and here to submit patent information—(1) Original NDA.
The declara- tions required by this section must be signed by the applicant or patent owner, or the applicant’s or patent owner’s attorney, agent (representa- tive), or other authorized official.(d) When and where to submit patent information—(1) Original NDA.
Source: Original NDA submission This reviewer again referred to the recent NDA submissions for the aripiprazole and risperidone adolescent schizophrenia programs to compare placebo response between the Russian sites in HGIN compared to the aripiprazole and risperidone pivotal schizophrenia trials.
Except as amended hereby, the Original NDA remains in full force and effect in accordance with its terms, and each party hereto confirms its obligations thereunder.
A.R. 708.D. In 2010, The FDA Approved Questcor’s Efficacy Supplement Application to Add Infantile Spasms to Acthar’s Label and Directed Questcor to Stop Using NDA Number 022432 in Favor of Acthar’s Original NDA Number 008372 In 2010, the FDA approved Questcor’s efficacy supplement application to add infantile spasms to Acthar’s label indications.
Original NDA: CMS had proposed to use “original NDA” to define an NDA as equivalent to an NDA filed by the manufacturer for approval under section 505 of the FFDCA for purposes of approval by FDA for safety and effectiveness.
As set forth in the chart below, the average time for FDA approval of these therapies was 221.6 days: Original NDA and Original BLA Approvals Filed By Bristol Myers and Celgene, 2014-2020 Shortest Days to Approval D.
Abbott shall prepare and provide to CTI for FDA submission the Original IND and Original NDA annual reports, to the extent applicable, and Periodic Report for the period of time during which the Original IND and Original NDA were owned by Abbott.
Jessup, Review and Evaluation of Pharmacology Toxicology Data: Original NDA Review (1996) (“the 1996 FDA SBOA”, Ex. 1007A).Public accessibility is based on the “facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Lister, 583 F.3d 1307, 1311 (Fed.
In a submission dated June 28, 2017, the applicant submitted an Original NDA, combination therapy of Tezacaftor/Ivacaftor for the proposed indication of Cystic Fibrosis (CF).