Regulatory Landscape of 505(b)(2) Application for Parenteral Dosage Form in USA & Case Studies for Parenteral Dosage Form: Deviations and CAPA in Pharmaceutical Industry

Abstract

505(b)(2) application is one of the three established types of regulatory submission and may be advantageous for pharmaceutical sponsors. 505(b)(2) is a type of New Drug Application (NDA). It was added to the Food, Drug & Cosmetic Act by the Drug Price Competition and patent term restoration Act of 1984. 505(b)(2) is a type of application which is midway between NDA and ANDA. Drug products that may be submitted under this section are not completely new products, yet they are not generics. These medications have both similarities and some differences from an innovator or brand drug. 505(b)(2) approval route was designed to encourage innovation and to eliminate costly and time-consuming duplicative clinical studies. 505(b)(2) application brings a modified version of an existing drug to market through potentially much faster and less costly way than starting with a new compound. In most 505(b)(2) cases, safety and efficacy information of the (RLD), both in terms of non-clinical and clinical portion, are relied upon, while minute additional data required to establish comparability with the RLD, are worked out.505(b)(2) is still a demanding process that requires thorough understanding of the FDA and how it works. In dissertation work, difference between 505(b)(1) & 505(b)(2) applications, 505(b)(2) approval process along with pre -IND meetings and Bio IND is described. In addition to that difference between parenteral & solid oral dosage form is also discussed.