miércoles, 23 de noviembre de 2016

GDUFA / Pediatric Drug Development / Medical Gas Containers

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry
This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance.
2. E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry
This draft guidance is an addendum to the guidance entitled ‘‘E11 Clinical Investigation of Medicinal Products in the Pediatric Population’’ (ICH E11 guidance), and is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug development.
3. Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
FDA is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gassupply system or container.