Fixed-Dose Combination Product Regulations

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA announced in late May its intent to release regulations this year on “fixed-dose combination and co-packaged drug and/or biological products.” The regulations will also apply to fixed dose drug/biological combination products and certain natural source and synthetic drugs. They will describe the circumstances under which the agency might waive the combination requirements for a particular product and address the issue of co-packaging. The regulation has been added to the agency’s “unified agenda,” which contains 33 proposed and final rules it hopes to publish by the end of calendar year 2015, most of which were announced late last year.
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