Zdrowie i gospodarka · 23/08/2001

FDA Releases Draft Guidance on Submitting Type V Drug Master Files

The FDA has made available a draft document outlining the circumstances under which the Center for Biologics Evaluation and Research (CBER) will accept Type V Drug Master Files without a letter of intent from the DMF holder, which can be used to support various applications such as IND, BLA, or NDA submissions.