Rx-360 summary of the FDA proposed rule for combination products
The proposed rule would harmonize the requirements for prescription and nonprescription products.
Rx-360 has produced a summary of the FDA proposed rule for combination products.
On 23 December 2015, FDA issued the proposed rule on “Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph”.
FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed rule would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.
Comments on the proposed rule must be submitted by 22 March 2016.
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