FDA revises guidance on changes to an approved NDA, ANDA

FDA has issued a revised guidance to help drugmakers determine how they should report postapproval manufacturing changes to new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Recommendations are provided for postapproval changes in these areas: components and composition, manufacturing sites, the manufacturing process, specifications, the container closure system, labeling, miscellaneous changes, and multiple related changes.

The revised guidance does not provide recommendations on the specific information that should be developed by an applicant to assess the effect of a change, instead advising applicants to look to the relevant guidances from the Center for Drug Evaluation and Research to find such recommendations. The revised guidance does not contain any substantive changes to the previously existing guidance, an FDA official said. However, the guidance notes that if its recommendations on reporting categories are different from those in previous guidances, the categories in this guidance supersede previous categories.

Comments on the revised guidance are due by April 8, 2005. To view the document, "Guidance for Industry on Changes to an Approved NDA or ANDA; Availability," Click Here.