FDA Rule on Fixed-Dose Combination Drugs Set for This Year
Monday, June 1, 2015
Source: FDA News
The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released last week.
The rule will also clarify the kinds of studies sponsors need to demonstrate that they’ve met the requirements for fixed-dose combination drugs.
The FDA also wants to extend the regulations to combinations of biological drug products and drug-biologic combinations and clarify when they would apply to certain natural source and synthetic drugs.