What is the 505(b)(2) Regulatory Pathway?
What Industry and Bench Scientists Need to Know: Part 2 of 3
The alphabet soup of regulatory terms can be difficult to understand. What is an NDA, ANDA, or 505(b) 2? Whether you are a bench scientist in a university laboratory or CEO of an emerging biotech you probably don’t have a full grasp of the regulatory hurdles that you must pass to get your new drug approved by the FDA. With the growing interest in new uses for existing drugs to treat any number of diseases, it is important to understand ways to expedite your path to FDA approval. In this series we will discuss how the FDA treats formulation changes, new dosage forms and changes in certain active ingredients under the abbreviated 505(b)(2) regulatory pathway.
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 advances medical care. A bench scientist may discover that a well-known and approved clinical antibiotic has anti-inflammatory capacity and potential to be use for chronic degenerative disease. These new indications and uses for already FDA approved drugs can be considered for approval using special abbreviated regulatory pathways that are differentiated by subtle characteristics.
This can result in a much less expensive and faster route to approval, compared with a traditional development path [such as 505(b)(1)] New Drug Application (NDA)], while creating new, differentiated products with tremendous commercial value.
| Regulatory Path | Drug Application | Data1 | Clinical trials required for Efficacy and Safety | Approving Agency |
| 505(b)1 | NDA | Stand-alone NDA that contains full reports of safety and effectiveness for a new molecular entitity | Yes | Office of New Drugs |
| 505(b)2 | NDA | Reports of safety and effectiveness may come from studies not conducted by the sponsor.2 | Yes | Office of New Drugs |
| 505(j) | Abbreviated NDA (ANDA) | Relies on clinical data that demonstrate that the proposed product has a systemic exposure or therapeutic effect that is not different from an approved reference listed drug (RLD)3 | No4 | Office of Generic Drugs |
- The precise scope and type of information necessary for approval will vary and is subject to the result of discussions between the applicant and the FDA.
- Assumes that the FDA has not published a finding of safety and efficacy and/or the applicant has not obtained a right of reference for use for the drug.
- An ANDA generally must contain information to show that the proposed generic product (a) is the same as the RLD with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences) and (b) is bioequivalent to the RLD.
- An ANDA may contain clinical investigations to establish the safety and effectiveness of the proposed drug product if systemic levels cannot be measured. In general no clinical studies are needed for oral and IV solutions generic products for RLDs. Clinical studies for bioequivalence are needed for oral and parenteral routes (intramuscular, nasal) where systemic exposure can be assessed.
About the Author:
Kenneth Duchin, PhD. is an experienced clinical pharmacologist with extensive drug development experience in a broad range of therapeutic areas (e.g., oncology, urology, diabetes, CNS, CV, GI). He has led several registration programs and authored regulatory documents to support regulatory filings.
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