Zdrowie i gospodarka · 8.12.1999

Draft Guidance for Industry on Applications Covered by Section 505(b)(2); Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Applications Covered by Section 505(b)(2).'' A section 505(b)(2) application is a new drug application (NDA) 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. This draft guidance also provides information on procedures for submitting an application for approval of a change from an approved drug.