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

Online Course • grapl

About the CPD course

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical product for marketing and sale in the USA. This module sets out the FDA’s requirements for content and formatting of the NDA; details the process by which the agency reviews and approves an application; and describes the applicant’s actions in that process. Mechanisms for expedited drug development and review; including breakthrough therapy designation; are also outlined. The module is up to date with the seventh reauthorisation of the Prescription Drug User Fee Act (PDUFA VII).

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grapl

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grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.