FDA AIMS TO ISSUE PROPOSED RULE ON COMBINATION PRODUCTS NEXT SPRING

The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at a recent industry conference.

The proposed rule follows a draft guidance on the subject issued Sept. 29, 2004, by the Office of Combination Products (OCP), James Cohen, senior adviser to the office, said. "To date the FDA has not promulgated regulations on cGMP requirements for combination products. Instead we have provisions from the applicable regulations for drugs, devices and biologic products," Cohen said in a speech at the Regulatory Affairs Professionals Society annual conference in Baltimore Oct. 16.

In developing the proposed rule, OCP has taken into account the comments it received on the draft guidance, of which there were about 15 that were "generally supportive," Cohen said. The office is trying to "clarify and streamline the regulatory scheme [and] provide a flexible quality management framework," while avoiding "duplicative" regulation of manufacturers.

Since there are significant differences in cGMP regulations for drugs and devices, manufacturers of products that bridge these two areas want clarification as to which rules they have to follow. Devices are covered by the quality systems regulation (QSR) issued by the Center for Devices and Radiological Health, so manufacturers want to know "if it's a drug and device [combination], do I have to do the entire QSR?" Cohen said.

The 2004 draft guidance can be seen at www.fda.gov/oc/combination/OCLove1dft.html (http://www.fda.gov/oc/combination/OCLove1dft.html).