What is 505(b)(2)?
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. A (b) (2) application is a new drug application (NDA) described in section (b) (2) of the Act. It is submitted under section (b) (1) of the Act and approved under section (c) of the.
The b 2 is a New Drug Application NDA mechanism which allows an applicant to seek 22 for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference.
Created init is a streamlined process and does not require the applicant to conduct all the required studies or obtain a right of reference. It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being wat cost.
The intent of this pathway is to lower 50 cost of development, and speed approvals, and encourage innovation. For applicants this id. Because of these benefits, b 2 s have become popular. The FDA approves twice as many b 2 applications as the b 1. They are projected to become increasingly widely used over the next few years, as the b 2 submission mechanism is one of the most useful approaches out of the FDA.
By leveraging the original b 1 or existing published literature, the FDA has whxt applicants a aa path to approval. Want to learn more about b 1? Grab our free whitepaper: Successfully Submitting An Application via the b 2. Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution. It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being lower cost What is the b 2?
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DRUG CANDIDATES WITH 505(B)(2) POTENTIAL
The (b) (2) new drug application (NDA) is one of the three and was created by the Hatch-Waxman Amendments of , with (b) (2) referring to a specific section of the U.S. Federal Food, Drug, and Cosmetic Act. The (b) (2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference. Apr 15, · Many potential drug product developers are not familiar with the different abbreviated approval pathways for drug products under the FD&C Act — the abbreviated approval pathways .
The b 2 new drug application NDA is one of three U. Food and Drug Administration FDA drug approval pathways and represents an appealing regulatory strategy for many clients. A b 2 NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant.
This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as b 1 ], while creating new, differentiated products with tremendous commercial value. Full application — Data predominantly obtained from studies conducted by and for the sponsor. A company may wish to create a new dosage form that is faster acting, combines two active ingredients in a novel way, or provides a route of administration or mechanism of drug delivery that patients or doctors prefer over previous versions.
Also, a company may wish to seek approval for a new indication for an already-approved drug or carry out an Rx-to-OTC switch. Such new products often contain well-understood active ingredients that are present in existing, approved drug products reference drugs ; so, companies must only create a bridge between what is already known about the previously approved reference drug and the novel drug product or indication.
The b 2 NDA pathway makes this possible. Candidate Identification While the b 2 pathway offers a unique opportunity for rapid approval, success hinges on identifying products that have documented market differentiation, low development risk and high-profit potential. Biological therapeutics, so-called biosimilars, are not suitable for approval under the b 2 pathway. Candidate Assessment Predevelopment assessment of candidates is essential to establish the value proposition of a product concept for investors and to reduce the risk of costly errors.
Does the science make sense? For instance, is the formulation stable and readily prepared? Is manufacturing scalable? Are active and inactive ingredients available and affordable? Does the product have a clear niche in the medical specialty? Is it effective for solving a unique problem or solving a problem in a unique way?
Is there evidence the product would be appealing to the proposed patient population? What clinical trials or other data will be required to gain approval? Can development be expedited? What distinguishing information can be presented on the labeling for eventual promotional activity?
Is there a viable market for the product? What is the potential for future competition or substitution? What is needed to ensure reimbursement? What is the optimal pricing? Typically, achieving drug approval under the b 1 pathway—which requires the completion of new studies to establish the safety and efficacy of the drug in a specified disease or condition—can cost the sponsor up to 15 years and a billion dollars.
The accelerated path to approval and prospect of exclusivity make b 2 a cost-effective and commercially attractive route, but one with key differences from traditional b 1 development. Together, these differences represent a formidable multifaceted challenge. When mishandled, the early steps of b 2 development can end in product-development failure. On the other hand, when managed skillfully, these first steps can result in important victories for the sponsor, including reduced costs, a clear path to approval and immediate interest from investors.
How to Achieve Success for b 2. Skip links Skip to primary navigation Skip to content. What is b 2? BENEFITS OF B 2 b 2 is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests.
Ideal b 2 candidates include: Drugs with new indications Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration New combination products Prodrugs of an existing drug In some cases, drugs with new active ingredients Potential types of b 2 s include: Branded generics DESI drugs Prodrugs Orphan drugs Drug-device combinations Biological therapeutics, so-called biosimilars, are not suitable for approval under the b 2 pathway.
Feasibility: Candidate Assessment Predevelopment assessment of candidates is essential to establish the value proposition of a product concept for investors and to reduce the risk of costly errors.
Scientific Viability Does the science make sense? Medical Viability Does the product have a clear niche in the medical specialty?
Regulatory Viability What clinical trials or other data will be required to gain approval? Commercial Viability Is there a viable market for the product? Pre-IND: The b 1 pre-IND development process is fairly straightforward: conduct required nonclinical animal pharmacology, pharmacokinetics and toxicology studies; carry out early pre-formulation studies and select a lead formulation to advance; develop appropriate analytical methods; gather stability data on the active ingredient and the dosage form; and develop a proposed clinical protocol; complete a pre-IND consultation with the FDA in which the sponsor presents findings from its nonclinical studies and manufacturing and analytical data, as well as a proposed clinical trial, in order to gain FDA agreement to move to human testing; and file the investigational new drug IND application.
Compared to b 1 , the b 2 process differs greatly. In proposing a b 2 development strategy in a pre-IND meeting, the objective is to gain FDA input and concurrence with the studies, with the chemistry, manufacturing, and controls CMC strategy and with clinical research plans in a way that minimizes the number of new studies required.
For many companies, obtaining FDA buy-in and successfully activating an IND are critical steps for securing investments. Timing of CMC work: For a b 2 product, the clinical trial materials for Phase I studies often demonstrations of clinical bioequivalence must be representative of the commercial manufacturing process, including packaging. In general, the three stability batches that will be used for shelf-life determinations are also prepared at this time.
Timing of studies: Because b 2 development plans rely largely on pre-existing data, and clinical studies can often be started simultaneously and developed in parallel, significantly shortening the overall time to market.