Draft Guidance on Implementing GDUFA II By FDA

The US FDA revised draft guidance on the generic drug user fee program (GDUFA II) which serves the new fee structure and types of fees will be assessed. (more…)

MHRA Offers Guidance on Comparator products in BE/TE studies after Brexit

MHRA provides No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies. This guidance provides further information on comparator products used in studies supporting abridged marketing authorisation applications in a no-deal Brexit. (more…)

FDA Guidance on Submitting Manufacturing Facility Information

The US Food and Drug Administration (FDA) finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. (more…)

EMA Issues Guideline for Wording of Therapeutic Indication

The European Medicines Agency (EMA) released a guidance developed by Committee for Medical Products for Human Use (CHMP) on the wording of therapeutic indications is consistent across products. (more…)

FDA Revised Draft Guidance on Drug Master Files

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Drug Master Files.” Once finalized, this guidance will provide FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. This draft guidance, when finalized, will revise the guidance for industry “Drug Master Files: Guidelines” that published in September 1989. (more…)