FDA Urged to Clarify Voluntary Quality Standards for Combination Products

A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards.

The Combination Products Coalition (CPC), a Washington, DC-based trade association, is asking the FDA to clarify the scope of CDER’s proposed voluntary quality guidance, including how it will integrate with standards laid out by CDRH and what types of standards it expects CDER to adopt.

In January, the agency issued a draft policy guidance that would allow CDER officials to “informally recognize” voluntary consensus standards related to pharmaceutical quality that are potentially useful to industry and CDER staff. The comment period closed on Monday.

The coalition says it supports the principles behind the draft guidance but worries that the “relatively broad” wording may be confusing for companies that make combination products.