FDA Issues List of Guidances Planned for 2015

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-12-2015 09:19

The US Food and Drug Administration (FDA) has published its list of either new or revised draft guidances that the Center for Drug Evaluation and Research (CDER) is planning to publish during calendar year 2015. Key categories are for biosimilarity, pharmaceutical quality, and pharmaceutical manufacturing.

With respect to biosimilarity, the FDA said it plans to address four guidances as follows:
• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
• Considerations in Demonstrating Interchangeability to a Reference Product
• Labeling for Biosimilar Biological Products
• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

With regard to pharmaceutical quality and chemistry, manufacturing, and controls, the FDA has identified a number of guidances it plans to issue:
• Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
• Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
• Botanical Drug Development
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Development of Near Infrared Spectroscopy (NIR) Procedures
• Drug Products Containing Nanomaterials
• Elemental Impurities in Drug Products Marketed in the United States
• Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity
• Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation
• Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
• Quality Metrics and Risk-Based Inspections
• Specified Biotechnology and Specified Synthetic Biological Products – Annual Report

With respect to pharmaceutical quality/manufacturing standards (CGMP), the FDA has identified several guidances it plans to issue in 2015 
• cGMP Data Integrity Questions and Answers
• Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding)
• Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities

Source: FDA

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