RAPS: Proposed Rule Would Revise Regulations on Fixed-Combination Drugs

The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and co-packaged drugs, as well as to combinations of over-the-counter active ingredients.Under its authority to require evidence demonstrating that prescription fixed-combination or co-packaged drugs and OTC ingredients provide enhanced safety or effectiveness and can be labeled as such, this proposed rule (which would not apply to drug-device combinations) describes what applicants must do to show that their fixed-combo or co-packaged drugs are safe and effective.

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