FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

The United States Food and Drug Administration (FDA) can approve small molecule drugs and some biologics under the regulatory pathway 505(b)2.

The 505(b)2 regulatory pathway allows an applicant to submit a new drug application for approval of different formulations, dosage forms, indications or combination products of drugs and biologics that have been already approved by the FDA.

Basically, 505(b)2 permits an applicant to rely on the safety and effectiveness data of a previously-approved product.

More specifically, an application under the 505(b)2 is one for which one or more of the investigations relied upon by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted according to the applicable law.