Pharmaceutical Development and Commercialization (b)(2) | Camargo

 

505 b 2 application process

This guidance identifies the types of applications that are covered by section (b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). A (b)(2) application is a new drug application. (b)(2) Applications and ANDAs I.C Amendments or Supplements to a (b)(2) Application for a Different Drug and Amendments or Supplements to an ANDA That Reference a . What is (b)(2)? The (b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. Read more.


FDA’s (b)(2) Application | Upadhye Cwik LLP


Forgot Password? Sign Up. Quick Links. Case Study: Albuterol. View all articles. ANDA is used to gain approval for a generic version of a drug that is already on the market. Earning approval through this pathway involves the manufacturer providing evidence 505 b 2 application process the FDA that the generic product is comparable to the currently approved product through analytical chemistry and bioequivalence evaluations.

The approved indication, dose route, and strength for the generic will be the same as the original or reference product. The pathway is abbreviated because preclinical and clinical trials are not required. These studies were performed by the manufacturer of the original product and reviewed by the FDA as part of the approval process, so it would be redundant for the generic manufacturer to complete similar trials again, 505 b 2 application process.

These drugs are not strictly generics, but are often not entirely novel new molecular entities either. The manufacturer of the b 2 eligible product needs to build a connection between their version of the product, or the active ingredients in it, and the reference product.

For example, this could include data and results of bioanalytical testing, pre-clinical studies, 505 b 2 application process, or even clinical trial results. While the b 2 path allows for using the research of others as a component of their FDA submission, the manufacturer of the b 2 product may still need to complete some of their own research in 505 b 2 application process areas to help fulfill all the various requirements of the FDA to earn approval.

The ability to utilize previously completed research as part of the FDA submission can save a great deal of time and money compared to the traditional full NDA. Additionally, a drug being approved through this pathway is not a simple generic of a previously approved product, so it may reach additional patients or perhaps be an improvement over a currently available treatment.

Manufacturers have recognized the potential benefits of b 2 with 48 drugs gaining FDA approval through the pathway ina new yearly high since at least prior to References 1. What is b 2? Camargo Pharmaceutical Services website. Accessed October 27, Food and Drug Administration website. US FDA website. Gaffney A. Kumar M, Jethwani H. Accessed October 30, King J. Ryan Chandanais is currently employed as an Emerging Therapeutics Analyst at a specialty pharmacy.

His job is to gather, analyze, and present pipeline intelligence involving specialty drug products. He has additional drug development-related experience at a contract research organization for pre-clinical studies, where he served as a Research Associate and Report Coordinator.

Personalize the information you receive by selecting targeted content and special offers.

 

Applications Covered by Section (b)(2) | FDA

 

505 b 2 application process

 

Oct 31,  · (b)(2) may represent an appealing pathway for drug approval for manufacturers for certain products. The ability to utilize previously completed research as part of the FDA submission can save a great deal of time and money compared to the traditional full NDA. What is (b)(2)? The (b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. Read more. The (b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work.