Submitter Revises

When an NDA nears approval, agency reviewers evaluate draft package labeling for accuracy and consistency with the regulatory requirements for applicable prescription or over-the-counter drugs. Each element of the proposed labeling, including indications, use instructions, and warnings, is evaluated in terms of conclusions drawn from animal and human testing. All claims, instructions, and precautions must accurately reflect submitted clinical results.

If CDER has concerns about the draft labeling, the Center will contact the submitter detailing suggested revisions. CDER comments can relate to almost any aspect of the proposed labeling. For example, CDER can comment upon drug indications and warnings, or suggest general changes in wording and format.

The labeling "negotiation process," through which a drug's final approved labeling is agreed upon, can take a few weeks to many months. The length of the process depends upon the number of agency comments and an applicant's willingness to reach agreement. Sometimes a submitter will submit several revisions of labeling before agreement with FDA on the labeling can be reached.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.