sábado, 11 de junio de 2016

Compounding/ Charging for Investigational Drugs/ Genomics/ Biosimilars - New Policy & Guidances

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

1. FDA finalizes interim policy on compounding using bulk drug substances
Today the FDA issued two final guidances on compounding using bulk substances:
The agency also posted a statement and a webpage related to these two guidances: 
For more information on pharmacy compounding, go to FDA’s Information on Compounding
2. Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Guidance for Industry
The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA received a number of questions concerning its implementation of the charging regulation. FDA is providing guidance in a question and answer format to address the most frequently asked questions about charging for investigational drugs under an IND.
3. E18 Genomic Sampling and Management of Genomic Data; International Council for Harmonisation; Draft Guidance for Industry
The draft guidance pertains to genomic sampling and to the management of genomic data in clinical studies. The focus of this draft guidance is on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data. The technical aspects of genomic sampling and research are also discussed when appropriate, recognizing the rapidly evolving technological advances in these areas. The draft guidance is intended to provide harmonized principles of genomic sampling and of managing genomic data in clinical studies.
4. Labeling for Biosimilar Products; Draft Guidance for Industry; Extension of Comment Period
FDA is extending the comment period for the notice entitled “Labeling for Biosimilar Products; Draft Guidance for Industry; Availability” that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments.

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