Federal Register Notice: FDA is making available a draft guidance for industry entitled New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products. It sets forth a change in the agency’s interpretation of the five-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products. If the guidance is finalized, a drug product will be eligible for five-year NCE exclusivity if it contains a drug substance that meets the definition of “new chemical entity,” regardless of whether that drug substance is approved alone or in certain fixed-combinations. To download this guidance, click here. To view this notice, click here.