FDA drafts guid­ance on Type V DMFs for com­bi­na­tion prod­ucts

The FDA on Mon­day is­sued draft guid­ance de­tail­ing when a Type V drug mas­ter file (DMF) can be used to pro­vide in­for­ma­tion about CDER-led com­bi­na­tion prod­ucts that in­clude a de­vice con­stituent that may be used in mul­ti­ple com­bi­na­tion prod­ucts.

DMFs are a vol­un­tary sub­mis­sion to the FDA of con­fi­den­tial in­for­ma­tion about cer­tain as­pects re­lat­ed to a drug or man­u­fac­tur­er. There are five types of DMFs, Type II-V (Type I DMFs were dis­con­tin­ued in 2000), with Type V DMFs cov­er­ing FDA ac­cept­ed ref­er­ence in­for­ma­tion that would not fit in the oth­er DMF types.

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