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USFDA Draft Guidance: Determining Whether to Submit an ANDA or a 505(b)(2) Application
Choosing the appropriate abbreviated approval pathway is an important consideration when developing a drug product for submission to the U.S. Food and Drug Administration (FDA). The pathway selected determines the type of information and data that can be used to support the application. The FDA has published the Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application, which provides recommendations to help applicants determine whether a propose
Sharan Murugan
13 hours ago7 min read