Section 505 B 2

The house amendment sec.

Section 505 b 2. Codified in 1984 the section 505 b 2 drug approval pathway lies part way between the regular new drug approval pathway and the generic drug approval pathway allowing changes in characteristics such as dose or dosage form and often requiring data beyond bioavailability studies. It is submitted under section 505 b 1 of the act and approved under section 505 c of the. The pathway was created by the hatch waxman amendments of 1984 with 505 b 2 referring to a section of the federal food drug and cosmetic act.

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 described in. 360bbb 1 dispute resolution. While 505 b 2 programs by definition require fewer and or smaller studies than 505 b 1 products the costs are significantly less in every phase of development.

505 b adopts the provision of the house bill allowing the trustee discretion in all cases whether to ask the internal revenue service or state or local tax authority for a prompt audit of his returns on behalf of the estate. Additionally it is more likely that nonclinical and clinical commitments for a 505 b 2 product can be met post market. 360bbb expanded access to unapproved therapies and diagnostics.

For example if a proposed product is considered a duplicate it must be filed as an anda. Section 505 b 2 of the food drug and cosmetic act as created under hatch waxman permits submission of a new drug application nda containing one or more investigations necessary to approval that were not conducted by the applicant and for which the applicant has no right of reference. The 505 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. The guidance effectively lays out regulatory section iv a and scientific section iv b requirements and considerations for each type of submission. Fd c act section number title.

It cannot be filed as a 505 b 2.