FDA Outlines Combination Contraceptive Labeling in New Draft Guidance

A new FDA draft guidance recommends sponsors include new class labeling and prescribing information for combined hormonal contraceptives containing estrogen and progestin.

The guidance covers statements for oral and non-oral contraceptives, such as transdermal systems and vaginal rings, and reflects the agency’s 2006 physician labeling rule and the 2015 pregnancy and lactation labeling rule. The rules govern the format and content of certain label sections.

The document takes the place of a previous draft guidance withdrawn by the agency in July 2015 was expanded to include a more general class of contraceptives. The new guidance does not cover instructions for patients.