FDA Sets Agenda for 2015 Guidance Development

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-02-02-2015, Volume 39, Issue 2

Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.


In releasing its annual list of proposed guidance for industry docments, for 2015, FDA’s Center for Drug Evaluation and Research (CDER) mapped an ambitious agenda for key areas. Of the 90 proposed documents listed on the guidance agenda for 2015, four focus on biosimilarity, 13 on pharmaceutical quality/CMC; and three on pharmaceutical quality/cGMPs. Quality metrics, elemental impurities, and supply-chain security are other key areas targeted for proposed guidances. 

FDA guidance documents are not legally enforceable, but describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited, FDA notes.

In December 2014, the International Conference on Harmonization (ICH) released long-awaited revisions to standards for elemental impurities in drug products, ICH Q3D Guideline for Elemental Impurities for implementation by regional authorities. In January 2015, the United States Pharmacopeial Convention announced an implementation timeline of January 2018; the European Medicines Agency set implementation for new drug products for June 2016 and existing products for December 2017. FDA has not announced implementation dates, but listed a guidance, Elemental Impurities in Drug Products Marketed in the United States, for release some time in 2015.

FDA’s 2015 guidance agenda includes six documents related to the implementation of the Drug Supply Chain Security Act (DSCSA). A December 2014 guidance, DSCSA Implementation: Product Tracing Requirements Compliance Policy, delayed enforcement of regulations for trading partners. Industry players have complained that FDA’s DSCSA-related guidance documents thus far have been limited and fail to answer questions presented by industry.

Proposed guidances include the following: 

Pharmaceutical Quality/CMC 


  • 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 

  • Drug Products Containing Nanomaterials Elemental Impurities in Drug Products Marketed in the United States 

  • Quality Metrics and Risk-Based Inspections

  • Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products 

  • Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing 

  • Specified Biotechnology and Specified Synthetic Biological Products-Annual Report


  • 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

Pharmaceutical Quality/Manufacturing Standards (CGMP) 

  • CGMP Data Integrity Questions and Answers 

  • Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding) 

Drug Supply-Chain Security

  • DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers 

  • DSCSA Implementation: Products Eligible for Grandfather Status 

  • DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs-Standardization of Data and Documentation Practices 

  • DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs 

  • DSCSA: Verification Systems for Prescription Drugs 

  • DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirement.

A complete list of proposed guidance documents is available on www.fda.gov. For draft and final guidances, FDA offers an online search to facilitate access to guidance documents. Users can search for documents by keywords, then filter results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Article DetailsPharmaceutical Technology
Vol. 39, Issue 2
Page: 24

When referring to this article, please cite it as:
R. Peters, “FDA Sets Agenda for 2015 Guidance Development," Pharmaceutical Technology 39 (2) 2015.