The 505 (b) (2) application is one of three established types of regulatory submissions and may favor pharmaceutical sponsors. The FFDC defines the statutory submission of 505 (b) (2) as an NDA that includes a safety and efficacy investigation, most of which requires applicants to approve such an NDA. An applicant who is an applicant and has not obtained a reference right.
In most cases of 505(b) (2) NDA and (2), the safety and efficacy information of (RLD), both clinical and non-clinical, using the minimum additional data required to establish.
This document analyzes how to submit 505 (b) (2) by developing various alternatives, which are effective and safe in obtaining approval in a shorter period of time and avoiding the possibility. It is considered a submission route. Promote known risks and the potential for early launch at low cost.
Potential drug candidates 505(B) (2)
These new products often contain well-known active ingredients found in existing approved medicines. Therefore, companies only need to bridge what is already known about previously approved reference drugs and new drugs or indications.
The 505(b) (2) NDA route makes that possible. In Europe, regulatory approval routes similar to Route 505 (b) (2) are hybrid procedures under Article 10 of Directive 2001/83 / EC.
- 505(B)(2) Benefits
505 (b) (2) is of particular value to pharmaceutical and generic companies that want to benefit from a development process that eliminates most non-clinical studies while reducing competitiveness in the environment. Extensive safety and effectiveness testing.
- Relatively low risk due to pre-approval of drug
- Less research accelerates low-cost development
- May be subject to 3 years, 5 years, or 7 years of market exclusivity
The pre-IND development process for 505 (b) (1) is straightforward.
Conduct the required non-clinical (animal) pharmacology, pharmacokinetics, and toxicology studies. Conduct early pre-formulation studies and select key formulations to move forward. Develop an appropriate analysis method. Collect stability data on active ingredients and dosage forms. Develop a proposed clinical protocol.
After completing preclinical consultations with the FDA, the sponsor will submit the results of non-clinical studies, manufacturing, and analytical data, and the proposed clinical trials to obtain an FDA transition agreement. Human test; and submit an Investigational New Drug (IND) application.
Step Order: 505 (b) (2) process begins with a pre-IND meeting with the FDA, followed by formulation development (and research as needed), and then IND submission.
Pre-IND Meeting Goals: For 505 (b) (2) products, the PIND strategy is different than for 505 (b) (1). When proposing a 505 (b) (2) development strategy at a pre-IND meeting, the goal is to minimize the FDA’s views and research, chemistry, manufacturing, management (CMC) strategies, and the number of new studies required.