Course update: The New Drug Application (NDA) for Marketing Approval in the USA

Zenosis, the leading provider of eLearning for the medicinal products industry, has released an updated version of its course on applications to the US Food and Drug Administration (FDA) for marketing approval of new drugs.

Course SUB09, The New Drug Application (NDA) for Marketing Approval in the USA, has been updated to take account of the FDA’s commitment letter for authorisation VI of the Prescription Drug User Fee Act, which applies for US fiscal years 2018 through 2022. In addition, information on submission of applications has been updated in accordance with the FDA’s requirements for mandatory use of electronic Common Technical Document (eCTD) formatting and for transmission via its Electronic Submissions Gateway from 5 May 2017.

Information has also been updated on expedited development and review programmes and on communications and meetings between applicants and the FDA.