Regulatory Strategy
This section provides analysis of pertinent regulatory information to produce a recommended regulatory pathway. A thorough search of regulatory documents supports the regulatory recommendations (e.g., Dockets Management; HeinOnline[1]).
The 505(b)(2) regulatory pathway may be appropriate if part of the NDA application requirements can be supplied using information from published literature and/or the Agency’s findings of [...]
Archive for December 10th, 2007
505(b)(2) - Part 2: The Assessment: Regulatory Strategy
Published December 10th, 2007 in 505(b)(2) Process. 0 Comments505(b)(2) - Part 2: The Assessment: Clinical Development Plan
Published December 10th, 2007 in 505(b)(2) Process. 0 CommentsClinical Development PlanThe proposed Clinical Development Plan is dependent on the selected regulatory pathway. The Clinical Development Plan is based on available Agency study recommendations provided in the FDA Guidance for Industry documents, information in the public domain (e.g., PubMed), and information obtained from SBA documents as applicable.
The plan consists of the outline of each [...]
