Zdrowie i gospodarka · 23/12/2015

FDA Proposes Revisions to Regulations on Prescription Fixed-Combination Drugs for Over-the-Counter Use

The Food and Drug Administration (FDA) is proposing to revise its regulations on prescription fixed-combination drugs to include nonprescription fixed-combination and co-packaged drugs, as well as combinations of active ingredients for an over-the-counter (OTC) monograph. The proposed revisions aim to harmonize requirements for prescription and nonprescription products, aligning with the Agency's long-standing policy.