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SUB16: The 505(b)(2) Application for Marketing Approval in the USA

SUB16: The 505(b)(2) Application for Marketing Approval in the USA

  • 30 Day Money Back Guarantee
  • Completion Certificate
  • 24/7 Technical Support

Highlights

  • On-Demand course

  • 30 minutes

  • Intermediate level

Description

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

About The Provider

Zenosis
Zenosis
Dundee
We specialise in Pharmaceutical & Biotech courses for healthcare professionals, as well as a suite of essential courses for regulatory and statutory business compliance. As a member of the CPD, you can be assured that our courses meet exacting standards and deliver a compelli...
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